<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01705080</url>
  </required_header>
  <id_info>
    <org_study_id>1201</org_study_id>
    <nct_id>NCT01705080</nct_id>
  </id_info>
  <brief_title>IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN</brief_title>
  <acronym>EnligHTN-II</acronym>
  <official_title>IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post market clinical investigation is to further evaluate the safety and&#xD;
      performance of the EnligHTN™ Renal Denervation System in the treatment of patients with&#xD;
      uncontrolled hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post market, prospective, multicenter, non-randomized, single arm study of the&#xD;
      EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension&#xD;
      will undergo renal artery ablation at approximately 40 investigational sites located&#xD;
      internationally and will be followed up to five years post procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Abbott made a decision to not further develop the RDN program.&#xD;
  </why_stopped>
  <start_date type="Actual">January 17, 2013</start_date>
  <completion_date type="Actual">November 27, 2019</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months</measure>
    <time_frame>Confirmatory visit to 6 months</time_frame>
    <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years</measure>
    <time_frame>2 years</time_frame>
    <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years</measure>
    <time_frame>5 years</time_frame>
    <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years</measure>
    <time_frame>Confirmatory visit to 2 years</time_frame>
    <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years</measure>
    <time_frame>Confirmatory visit to 5 years</time_frame>
    <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieved Office Systolic Blood Pressure &lt; 140 mmHg at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The percentage of participants achieved office systolic blood pressure &lt;140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure &lt;140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation</measure>
    <time_frame>Baseline to 2 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation</measure>
    <time_frame>Baseline to 3 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation</measure>
    <time_frame>Baseline to 4 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation</measure>
    <time_frame>Baseline to 5 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation</measure>
    <time_frame>Baseline to 2 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation</measure>
    <time_frame>Baseline to 3 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation</measure>
    <time_frame>Baseline to 4 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation</measure>
    <time_frame>Baseline to 5 years</time_frame>
    <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation</measure>
    <time_frame>Baseline to 2 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation</measure>
    <time_frame>Baseline to 3 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation</measure>
    <time_frame>Baseline to 4 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation</measure>
    <time_frame>Baseline to 5 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation</measure>
    <time_frame>Baseline to 2 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation</measure>
    <time_frame>Baseline to 3 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation</measure>
    <time_frame>Baseline to 4 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation</measure>
    <time_frame>Baseline to 5 years</time_frame>
    <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">276</enrollment>
  <condition>Hypertension</condition>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>A - EnligHTN for Severe Resistant HTN</arm_group_label>
    <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - EnligHTN for Resistant HTN</arm_group_label>
    <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C - EnligHTN for Resistant HTN &amp; CKD</arm_group_label>
    <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Patient has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EnligHTN</intervention_name>
    <description>Renal artery ablation with EnligHTN system used for all groups</description>
    <arm_group_label>A - EnligHTN for Severe Resistant HTN</arm_group_label>
    <arm_group_label>B - EnligHTN for Resistant HTN</arm_group_label>
    <arm_group_label>C - EnligHTN for Resistant HTN &amp; CKD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with uncontrolled hypertension&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥ 18 years of age at time of consent&#xD;
&#xD;
          -  Subject must be able and willing to provide written informed consent&#xD;
&#xD;
          -  Subject must be able and willing to comply with the required follow-up schedule&#xD;
&#xD;
          -  Subject has office Systolic Blood Pressure ≥ 140 mmHg at confirmatory visit&#xD;
&#xD;
          -  Subject has a daytime mean Systolic Ambulatory Blood Pressure &gt; 135 mmHg within 90&#xD;
             days prior to procedure&#xD;
&#xD;
          -  Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is on&#xD;
             a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3&#xD;
             anti-hypertensive medications (including 1 diuretic) or subject has a documented drug&#xD;
             intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB,&#xD;
             Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3&#xD;
             anti-hypertensive drugs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has significant renovascular abnormalities such as renal artery stenosis &gt; 30%&#xD;
&#xD;
          -  Subject has undergone prior renal angioplasty, renal denervation, indwelling renal&#xD;
             stents, and/or abdominal aortic stent grafts&#xD;
&#xD;
          -  Subject has hemodynamically significant valvular heart disease as determined by study&#xD;
             investigator&#xD;
&#xD;
          -  Subject has a life expectancy less than 12 months, as determined by the Investigator&#xD;
&#xD;
          -  Subject is participating in another clinical study which has the potential to impact&#xD;
             their hypertension management (pharmaceutical/device/homeopathic)&#xD;
&#xD;
          -  Subject is pregnant, nursing, or of childbearing potential and is not using adequate&#xD;
             contraceptive methods&#xD;
&#xD;
          -  Subject has active systemic infection&#xD;
&#xD;
          -  Subject has renal arteries with diameter(s) &lt; 4 mm in diameter&#xD;
&#xD;
          -  Subject has an estimated GFR &lt;15 mL/min per 1.73 m^2 using the MDRD formula&#xD;
&#xD;
          -  Subject had a renal transplant or is awaiting a renal transplant&#xD;
&#xD;
          -  Subject has blood clotting abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melvin Lobo, MBChB PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIHR Barts Cardiovascular Biomedical Research Unit</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Worthley, MB BS PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Adelaide Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital - City Campus</name>
      <address>
        <city>Parkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Besancon - Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <state>Franche-Comte</state>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Cardio. Paris-Sud-Institut Jacques Cartier</name>
      <address>
        <city>Paris</city>
        <state>Massy</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Etienne CHU</name>
      <address>
        <city>St. Etienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Civil - Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Coburg GmbH</name>
      <address>
        <city>Coburg</city>
        <state>Bavaria</state>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Ingolstadt GmbH</name>
      <address>
        <city>Ingolstadt</city>
        <state>Bavaria</state>
        <zip>85049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff-Klinik gGmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <state>Hesse</state>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz-und Diabetes Zentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>Nordrhein Westfalen</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni-Klinik Leipzig, Intervent. Angiologie</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitats-Herzzentrum Freiburg - Bad Krozingen</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jüdisches Krankenhaus Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13347</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Essen (AoR)</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johannes-Gutenberg-Universitat</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Bruder</name>
      <address>
        <city>Trier</city>
        <zip>54292</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Athens, Ippocration Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana Gabriele Monasterio CNR</name>
      <address>
        <city>Massa</city>
        <state>Tuscany</state>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S.Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino</name>
      <address>
        <city>Milano</city>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haga Ziekenhuis Locatie Leyenburg</name>
      <address>
        <city>Den Haag</city>
        <zip>2545 CH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Public Hospital</name>
      <address>
        <city>Dunedin</city>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland Universitetssykehus</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs University Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>San Sebastián</city>
        <state>Basque</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital Gothenburg</name>
      <address>
        <city>Goteborg</city>
        <zip>S41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIHR Barts Cardiovascular Biomedical Research Unit</name>
      <address>
        <city>London</city>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern General Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
    <country>Finland</country>
  </removed_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>December 21, 2017</results_first_submitted>
  <results_first_submitted_qc>December 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2018</results_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Denervation</keyword>
  <keyword>Renal artery</keyword>
  <keyword>EnligHTN™ Renal Denervation System</keyword>
  <keyword>Renal Artery Ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 16, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT01705080/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 276 subjects who underwent renal artery ablation fell into the analysis population of three predefined arms at 33 investigational sites located throughout Europe and Australia. The enrollment began on January 2013 and the last subject was enrolled on 06 September, 2016. The patients last follow-up visit occurred on 27 November, 2019.</recruitment_details>
      <pre_assignment_details>Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as &quot;unassigned arm&quot;. Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>A - EnligHTN for Severe Resistant HTN</title>
          <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="P2">
          <title>B - EnligHTN for Resistant HTN</title>
          <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="P3">
          <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
          <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Renal Artery Ablation Procedure</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Discharge Following Renal Artery Ablation Procedure</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="100">Reason Not Completed: Withdrawal by Subject=1</participants>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Missed visit</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as &quot;unassigned arm&quot;. Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.</population>
      <group_list>
        <group group_id="B1">
          <title>A - EnligHTN for Severe Resistant HTN</title>
          <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="B2">
          <title>B - EnligHTN for Resistant HTN</title>
          <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="B3">
          <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
          <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="147"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="276"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.6" spread="10.0"/>
                    <measurement group_id="B2" value="58.0" spread="11.8"/>
                    <measurement group_id="B3" value="68.5" spread="8.0"/>
                    <measurement group_id="B4" value="60.9" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Office Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Systolic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="180.4" spread="22.3"/>
                    <measurement group_id="B2" value="160.8" spread="17.5"/>
                    <measurement group_id="B3" value="177.3" spread="22.3"/>
                    <measurement group_id="B4" value="172.9" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97.1" spread="16.3"/>
                    <measurement group_id="B2" value="91.2" spread="13.3"/>
                    <measurement group_id="B3" value="90.6" spread="13.2"/>
                    <measurement group_id="B4" value="94.3" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hour ambulatory blood pressure</title>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Systolic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159.0" spread="16.3"/>
                    <measurement group_id="B2" value="147.4" spread="12.3"/>
                    <measurement group_id="B3" value="161.8" spread="19.3"/>
                    <measurement group_id="B4" value="155.0" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.9" spread="13.1"/>
                    <measurement group_id="B2" value="87.0" spread="14.4"/>
                    <measurement group_id="B3" value="82.9" spread="15.6"/>
                    <measurement group_id="B4" value="87.6" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.9" spread="22.3"/>
                    <measurement group_id="O2" value="160.8" spread="17.9"/>
                    <measurement group_id="O3" value="177.1" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.2" spread="25.1"/>
                    <measurement group_id="O2" value="147.9" spread="17.2"/>
                    <measurement group_id="O3" value="158.7" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.7" spread="26.7"/>
                    <measurement group_id="O2" value="-12.9" spread="21.8"/>
                    <measurement group_id="O3" value="-18.3" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure</title>
        <description>The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.</description>
        <time_frame>30 days post procedure</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure</title>
          <description>The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months</title>
        <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
        <time_frame>6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months</title>
          <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months</title>
        <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
        <time_frame>Confirmatory visit to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months</title>
          <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Confirmatory visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.2" spread="20.2"/>
                    <measurement group_id="O2" value="78.6" spread="17.6"/>
                    <measurement group_id="O3" value="35.3" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5" spread="24.7"/>
                    <measurement group_id="O2" value="79.6" spread="19.6"/>
                    <measurement group_id="O3" value="41.3" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from confirmatory visit to 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="14.4"/>
                    <measurement group_id="O2" value="1.1" spread="13.5"/>
                    <measurement group_id="O3" value="5.9" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years</title>
        <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
        <time_frame>2 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years</title>
          <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years</title>
        <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
        <time_frame>5 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years</title>
          <description>The new renal artery stenosis (&gt;50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years</title>
        <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
        <time_frame>Confirmatory visit to 2 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years</title>
          <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Confirmatory visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" spread="17.4"/>
                    <measurement group_id="O2" value="78.4" spread="19.0"/>
                    <measurement group_id="O3" value="36.3" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.4" spread="21.6"/>
                    <measurement group_id="O2" value="77.7" spread="19.0"/>
                    <measurement group_id="O3" value="41.1" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from confirmatory visit to 2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="15.8"/>
                    <measurement group_id="O2" value="-0.7" spread="14.9"/>
                    <measurement group_id="O3" value="4.8" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years</title>
        <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
        <time_frame>Confirmatory visit to 5 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years</title>
          <description>Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Confirmatory visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6" spread="14.7"/>
                    <measurement group_id="O2" value="80.8" spread="17.2"/>
                    <measurement group_id="O3" value="38.6" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" spread="20.0"/>
                    <measurement group_id="O2" value="77.0" spread="18.6"/>
                    <measurement group_id="O3" value="37.5" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from confirmatory visit to 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="17.3"/>
                    <measurement group_id="O2" value="-3.8" spread="15.7"/>
                    <measurement group_id="O3" value="-1.1" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.3" spread="15.7"/>
                    <measurement group_id="O2" value="147.0" spread="12.1"/>
                    <measurement group_id="O3" value="160.4" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.2" spread="18.2"/>
                    <measurement group_id="O2" value="142.7" spread="17.3"/>
                    <measurement group_id="O3" value="152.2" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="16.5"/>
                    <measurement group_id="O2" value="-4.3" spread="17.1"/>
                    <measurement group_id="O3" value="-8.1" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8" spread="12.7"/>
                    <measurement group_id="O2" value="86.8" spread="14.3"/>
                    <measurement group_id="O3" value="83.3" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5" spread="12.1"/>
                    <measurement group_id="O2" value="83.0" spread="12.5"/>
                    <measurement group_id="O3" value="78.1" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="9.3"/>
                    <measurement group_id="O2" value="-3.8" spread="13.4"/>
                    <measurement group_id="O3" value="-5.1" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" spread="16.2"/>
                    <measurement group_id="O2" value="91.2" spread="13.6"/>
                    <measurement group_id="O3" value="91.0" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.6" spread="15.6"/>
                    <measurement group_id="O2" value="86.0" spread="13.4"/>
                    <measurement group_id="O3" value="77.9" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.4" spread="13.9"/>
                    <measurement group_id="O2" value="-5.2" spread="12.2"/>
                    <measurement group_id="O3" value="-13.1" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieved Office Systolic Blood Pressure &lt; 140 mmHg at 6 Months</title>
        <description>The percentage of participants achieved office systolic blood pressure &lt;140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure &lt;140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.</description>
        <time_frame>6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieved Office Systolic Blood Pressure &lt; 140 mmHg at 6 Months</title>
          <description>The percentage of participants achieved office systolic blood pressure &lt;140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure &lt;140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 1 year</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180.0" spread="22.4"/>
                    <measurement group_id="O2" value="160.1" spread="17.6"/>
                    <measurement group_id="O3" value="176.8" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.4" spread="25.6"/>
                    <measurement group_id="O2" value="147.8" spread="20.8"/>
                    <measurement group_id="O3" value="159.8" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.6" spread="26.6"/>
                    <measurement group_id="O2" value="-12.3" spread="22.6"/>
                    <measurement group_id="O3" value="-17.0" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 2 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178.7" spread="22.0"/>
                    <measurement group_id="O2" value="158.5" spread="16.6"/>
                    <measurement group_id="O3" value="178.0" spread="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160.6" spread="26.5"/>
                    <measurement group_id="O2" value="144.3" spread="19.5"/>
                    <measurement group_id="O3" value="153.1" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.1" spread="29.0"/>
                    <measurement group_id="O2" value="-14.2" spread="20.9"/>
                    <measurement group_id="O3" value="-24.8" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 3 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.3" spread="21.9"/>
                    <measurement group_id="O2" value="160.7" spread="17.5"/>
                    <measurement group_id="O3" value="179.0" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.1" spread="28.5"/>
                    <measurement group_id="O2" value="143.8" spread="19.4"/>
                    <measurement group_id="O3" value="151.2" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.2" spread="34.1"/>
                    <measurement group_id="O2" value="-16.9" spread="23.1"/>
                    <measurement group_id="O3" value="-27.8" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 4 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177.7" spread="21.8"/>
                    <measurement group_id="O2" value="157.6" spread="15.4"/>
                    <measurement group_id="O3" value="180.4" spread="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156.2" spread="28.8"/>
                    <measurement group_id="O2" value="144.6" spread="25.3"/>
                    <measurement group_id="O3" value="146.9" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.5" spread="35.4"/>
                    <measurement group_id="O2" value="-13.0" spread="24.9"/>
                    <measurement group_id="O3" value="-33.5" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 5 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176.2" spread="20.3"/>
                    <measurement group_id="O2" value="160.2" spread="16.3"/>
                    <measurement group_id="O3" value="184.8" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.8" spread="22.6"/>
                    <measurement group_id="O2" value="144.4" spread="21.8"/>
                    <measurement group_id="O3" value="152.8" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.4" spread="28.4"/>
                    <measurement group_id="O2" value="-15.7" spread="24.8"/>
                    <measurement group_id="O3" value="-32.0" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 1 year</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" spread="16.6"/>
                    <measurement group_id="O2" value="91.0" spread="13.5"/>
                    <measurement group_id="O3" value="91.5" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" spread="17.6"/>
                    <measurement group_id="O2" value="85.5" spread="13.7"/>
                    <measurement group_id="O3" value="78.5" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.9" spread="15.0"/>
                    <measurement group_id="O2" value="-5.5" spread="13.2"/>
                    <measurement group_id="O3" value="-13.0" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 2 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1" spread="16.8"/>
                    <measurement group_id="O2" value="91.0" spread="12.7"/>
                    <measurement group_id="O3" value="92.0" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.2" spread="16.6"/>
                    <measurement group_id="O2" value="83.4" spread="13.0"/>
                    <measurement group_id="O3" value="75.2" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.9" spread="16.5"/>
                    <measurement group_id="O2" value="-7.6" spread="12.3"/>
                    <measurement group_id="O3" value="-16.8" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 3 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" spread="17.5"/>
                    <measurement group_id="O2" value="92.0" spread="13.2"/>
                    <measurement group_id="O3" value="91.3" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1" spread="15.8"/>
                    <measurement group_id="O2" value="82.9" spread="12.8"/>
                    <measurement group_id="O3" value="76.6" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.5" spread="18.4"/>
                    <measurement group_id="O2" value="-9.0" spread="12.6"/>
                    <measurement group_id="O3" value="-14.7" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 4 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.5" spread="17.5"/>
                    <measurement group_id="O2" value="91.0" spread="12.7"/>
                    <measurement group_id="O3" value="93.2" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2" spread="13.5"/>
                    <measurement group_id="O2" value="85.2" spread="16.3"/>
                    <measurement group_id="O3" value="77.2" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.3" spread="18.2"/>
                    <measurement group_id="O2" value="-5.9" spread="13.4"/>
                    <measurement group_id="O3" value="-16.0" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
        <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
        <time_frame>Baseline to 5 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
          <description>Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4" spread="17.3"/>
                    <measurement group_id="O2" value="93.1" spread="12.8"/>
                    <measurement group_id="O3" value="95.8" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.9" spread="11.7"/>
                    <measurement group_id="O2" value="85.1" spread="16.1"/>
                    <measurement group_id="O3" value="78.7" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.4" spread="14.4"/>
                    <measurement group_id="O2" value="-8.0" spread="14.5"/>
                    <measurement group_id="O3" value="-17.1" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 1 year</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.1" spread="16.1"/>
                    <measurement group_id="O2" value="146.8" spread="11.4"/>
                    <measurement group_id="O3" value="163.9" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.0" spread="18.7"/>
                    <measurement group_id="O2" value="141.7" spread="17.3"/>
                    <measurement group_id="O3" value="148.2" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="18.3"/>
                    <measurement group_id="O2" value="-5.1" spread="16.8"/>
                    <measurement group_id="O3" value="-15.8" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 2 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.5" spread="15.8"/>
                    <measurement group_id="O2" value="146.7" spread="11.8"/>
                    <measurement group_id="O3" value="159.9" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148.0" spread="17.2"/>
                    <measurement group_id="O2" value="139.5" spread="15.0"/>
                    <measurement group_id="O3" value="144.0" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.5" spread="18.6"/>
                    <measurement group_id="O2" value="-7.2" spread="16.0"/>
                    <measurement group_id="O3" value="-15.9" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 3 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.8" spread="15.9"/>
                    <measurement group_id="O2" value="147.0" spread="11.9"/>
                    <measurement group_id="O3" value="156.0" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.2" spread="19.3"/>
                    <measurement group_id="O2" value="139.8" spread="18.1"/>
                    <measurement group_id="O3" value="151.2" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.6" spread="21.5"/>
                    <measurement group_id="O2" value="-7.2" spread="18.8"/>
                    <measurement group_id="O3" value="-4.8" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 4 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.2" spread="14.5"/>
                    <measurement group_id="O2" value="146.3" spread="11.7"/>
                    <measurement group_id="O3" value="158.4" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.3" spread="19.6"/>
                    <measurement group_id="O2" value="137.9" spread="19.1"/>
                    <measurement group_id="O3" value="151.6" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.9" spread="22.4"/>
                    <measurement group_id="O2" value="-8.5" spread="17.8"/>
                    <measurement group_id="O3" value="-6.8" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 5 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.2" spread="14.9"/>
                    <measurement group_id="O2" value="143.7" spread="9.8"/>
                    <measurement group_id="O3" value="158.0" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.0" spread="17.8"/>
                    <measurement group_id="O2" value="133.3" spread="13.4"/>
                    <measurement group_id="O3" value="146.3" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.1" spread="22.0"/>
                    <measurement group_id="O2" value="-10.4" spread="11.8"/>
                    <measurement group_id="O3" value="-11.7" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 1 year</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.1" spread="12.9"/>
                    <measurement group_id="O2" value="86.2" spread="14.1"/>
                    <measurement group_id="O3" value="85.4" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.7" spread="12.0"/>
                    <measurement group_id="O2" value="81.9" spread="12.2"/>
                    <measurement group_id="O3" value="77.7" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="10.4"/>
                    <measurement group_id="O2" value="-4.4" spread="13.4"/>
                    <measurement group_id="O3" value="-7.6" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 2 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.6" spread="13.2"/>
                    <measurement group_id="O2" value="86.6" spread="14.2"/>
                    <measurement group_id="O3" value="84.6" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8" spread="12.0"/>
                    <measurement group_id="O2" value="81.5" spread="11.4"/>
                    <measurement group_id="O3" value="76.9" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="10.4"/>
                    <measurement group_id="O2" value="-5.0" spread="12.3"/>
                    <measurement group_id="O3" value="-7.6" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 3 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.0" spread="12.9"/>
                    <measurement group_id="O2" value="87.7" spread="14.7"/>
                    <measurement group_id="O3" value="81.7" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.3" spread="11.2"/>
                    <measurement group_id="O2" value="81.2" spread="12.9"/>
                    <measurement group_id="O3" value="76.8" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.7" spread="13.8"/>
                    <measurement group_id="O2" value="-6.5" spread="13.9"/>
                    <measurement group_id="O3" value="-4.9" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 4 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4" spread="12.5"/>
                    <measurement group_id="O2" value="87.6" spread="14.8"/>
                    <measurement group_id="O3" value="82.1" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.3" spread="12.5"/>
                    <measurement group_id="O2" value="80.9" spread="13.4"/>
                    <measurement group_id="O3" value="78.1" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.1" spread="14.6"/>
                    <measurement group_id="O2" value="-6.6" spread="14.5"/>
                    <measurement group_id="O3" value="-4.0" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
        <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
        <time_frame>Baseline to 5 years</time_frame>
        <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A - EnligHTN for Severe Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O2">
            <title>B - EnligHTN for Resistant HTN</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
          <group group_id="O3">
            <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
            <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation</title>
          <description>24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.</description>
          <population>The number of participants analyzed includes subjects who were available at the time of analysis</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1" spread="13.1"/>
                    <measurement group_id="O2" value="87.9" spread="15.6"/>
                    <measurement group_id="O3" value="83.2" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" spread="10.7"/>
                    <measurement group_id="O2" value="78.5" spread="11.1"/>
                    <measurement group_id="O3" value="76.0" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="12.6"/>
                    <measurement group_id="O2" value="-9.4" spread="13.1"/>
                    <measurement group_id="O3" value="-7.2" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <desc>Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as &quot;unassigned arm&quot;. Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.</desc>
      <group_list>
        <group group_id="E1">
          <title>A - EnligHTN for Severe Resistant HTN</title>
          <description>Office systolic Blood Pressure ≥160 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="E2">
          <title>B - EnligHTN for Resistant HTN</title>
          <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
        <group group_id="E3">
          <title>C - EnligHTN for Resistant HTN &amp; CKD</title>
          <description>Office systolic Blood Pressure ≥140 mmHg&#xD;
Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.&#xD;
Participant has an estimated ≥15 GFR &lt;45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula&#xD;
EnligHTN: Renal artery ablation with EnligHTN system used for all groups</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 11.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemias</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Trauma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="6" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Anterior Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Aortic Valve Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Carotid Aneurysm-Aneurysm Of Left Internal Carotid Artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Congestive Heart Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Decompensated Heart Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Heart Failure</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="147"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Paroxysmal Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Persistent Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Right Ventricular Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>ST Segment Changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>SVC Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Second Degree Heart Block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Unstable Angina</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="147"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hearing loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal Tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Acute Abdomen</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Bleeding</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Perforated Appendix</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lacerations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Melena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Other-Bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Other-Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Other-Death Of Unknown Cause</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Other-Hemorrhagic Lymphocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Other-Non-Specifc Acute Lung Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bacteremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bacterial Infections</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bacterial Infections of the Skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Chlamydial Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infected Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia in the Compromised Host</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Allergic Dye Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>In-Stent Restenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Calf Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Disc Protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Tendon Tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign Prostatic Hyperplasia (BPH)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Kidney Tumor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pancreatic Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Subdural Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hemiparesis/Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hemorrhagic Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Ischemic Stroke</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lumbar Spondylosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Seizure/Convulsions/Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack (TIA)</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Renal Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Chronic Renal Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Kidney Pain/Flank Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal Congestion-Urinary Obstruction-Renal Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Ureteral Dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urethral Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infections</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pulmonary Edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Common Cold/Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Mediastinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cutaneous Abcesses</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial Hypertension/Hypertension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="147"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal Artery Dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal Artery Stenosis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="147"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renovascular Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Bleeding</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vasospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 11.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Heart Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Mobitz II Block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sick Sinus Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Bleed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Colon Polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Elective Procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Elective Surgery</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Other-Small Wedge Shaped Abnormalities In Both Kidneys In Keeping With Small Infarcts</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hip Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Low Back Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Muscle Twitch</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Osteoarthritis/Degenerative Joint Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign Mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Numbness-Numbness In Right Thigh</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Numbness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack (TIA)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Malposition or Malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Renal Function</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Kidney Pain/Flank Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostate Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal Artery Stenosis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Bleeding</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Bruise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Drainage</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="147"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Hematoma</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="147"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>VASC Vessel Perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vaso Vagal Response</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vasospasm</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="147"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Steven Madej</name_or_title>
      <organization>Abbott</organization>
      <phone>651-756-2230</phone>
      <email>smadej@sjm.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705080
org study id: 1201
nct id: NCT01705080
lead sponsor: 
has dmc: Yes
The purpose of this post market clinical investigation is to further evaluate the safety and
      performance of the EnligHTN™ Renal Denervation System in the treatment of patients with
      uncontrolled hypertension.
This is a post market, prospective, multicenter, non-randomized, single arm study of the
      EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension
      will undergo renal artery ablation at approximately 40 investigational sites located
      internationally and will be followed up to five years post procedure.
observational model: Cohort
time perspective: Prospective
measure: Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
time frame: Baseline to 6 months
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
time frame: 30 days post procedure
description: The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.
measure: Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
time frame: 6 months
description: The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
measure: Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
time frame: Confirmatory visit to 6 months
description: Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
measure: Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
time frame: 2 years
description: The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
measure: Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
time frame: 5 years
description: The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
measure: Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
time frame: Confirmatory visit to 2 years
description: Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
measure: Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
time frame: Confirmatory visit to 5 years
description: Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
time frame: Baseline to 6 months
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
time frame: Baseline to 6 months
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
time frame: Baseline to 6 months
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
time frame: 6 months
description: The percentage of participants achieved office systolic blood pressure <140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure <140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
time frame: Baseline to 1 year
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
time frame: Baseline to 2 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
time frame: Baseline to 3 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
time frame: Baseline to 4 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
time frame: Baseline to 5 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
time frame: Baseline to 1 year
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
time frame: Baseline to 2 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
time frame: Baseline to 3 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
time frame: Baseline to 4 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
time frame: Baseline to 5 years
description: Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
time frame: Baseline to 1 year
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
time frame: Baseline to 2 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
time frame: Baseline to 3 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
time frame: Baseline to 4 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
time frame: Baseline to 5 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
time frame: Baseline to 1 year
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
time frame: Baseline to 2 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
time frame: Baseline to 3 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
time frame: Baseline to 4 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
time frame: Baseline to 5 years
description: 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
arm group label: A - EnligHTN for Severe Resistant HTN
description: Office systolic Blood Pressure ≥160 mmHg
Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
arm group label: B - EnligHTN for Resistant HTN
description: Office systolic Blood Pressure ≥140 mmHg
Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
arm group label: C - EnligHTN for Resistant HTN & CKD
description: Office systolic Blood Pressure ≥140 mmHg
Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Patient has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
intervention type: Device
intervention name: EnligHTN
description: Renal artery ablation with EnligHTN system used for all groups
arm group label: A - EnligHTN for Severe Resistant HTN
arm group label: B - EnligHTN for Resistant HTN
arm group label: C - EnligHTN for Resistant HTN & CKD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melvin Lobo, MBChB PhD
role: Principal Investigator
affiliation: NIHR Barts Cardiovascular Biomedical Research Unit
last name: Stephen Worthley, MB BS PhD
role: Principal Investigator
affiliation: Royal Adelaide Hospital
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country: Australia
country: France
country: Germany
country: Greece
country: Italy
country: Netherlands
country: New Zealand
country: Norway
country: Spain
country: Sweden
country: United Kingdom
country: Austria
country: Finland
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No
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