xml: <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/NCT06036186</url>
    </required_header>
    <id_info>
      <org_study_id>BP011</org_study_id>
      <nct_id>NCT06036186</nct_id>
    </id_info>
    <brief_title>Study for the Treatment of Heart Failure With Preserved Ejection Fraction Associated With High Blood Pressure Using Right Atrial Pacing Controlled by the PressurePaceTM System</brief_title>
    <acronym>RelieveHFpEFII</acronym>
    <official_title>Early Feasibility, Randomized Crossover and Double-Blind Design, Study for the Treatment of Heart Failure With Preserved Ejection Fraction (HFpEF) Associated With Hypertension Utilizing Right Atrial Pacing Regulated by the PressurePace™ System (RelieveHFpEF-II)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BaroPace Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>JSS Medical Research Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>BaroPace Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a prospective, double blind, self-controlled, randomized, cross-over study to&#xD;
        evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with&#xD;
        preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePace™&#xD;
        system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber&#xD;
        pacemakers.&#xD;
  &#xD;
        The objective of this study is to show that blood pressure-controlled right atrial pacing&#xD;
        improves exercise tolerance, improves heart failure symptoms, and improves hypertension&#xD;
        control in subjects with HFpEF associated with hypertension compared to conventional&#xD;
        bradycardia pacing alone.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, double blind, self-controlled, randomized, cross-over study to&#xD;
        evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with&#xD;
        preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePace™&#xD;
        system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber&#xD;
        pacemakers. No surgery, intervention or implant will occur during this study. All subjects&#xD;
        enrolled in the study already have a dual chamber pacemaker implanted for standard clinical&#xD;
        indications.&#xD;
  &#xD;
        The objective of this study is to show that blood pressure-controlled right atrial pacing&#xD;
        improves exercise tolerance, improves heart failure symptoms and improves hypertension&#xD;
        control in subjects with HFpEF associated with hypertension compared to conventional&#xD;
        bradycardia pacing alone.&#xD;
  &#xD;
        Each subject will have an office/clinic visit. Once the subject signs informed consent, the&#xD;
        pacemaker will be interrogated by trained personnel. If all the inclusion/exclusion criteria&#xD;
        are met, then the pacemaker will be connected to the pacemaker manufacturer's interrogation&#xD;
        module which will be connected to the BaroPace interface. The system will run with clinical&#xD;
        oversight in the office to determine suitability for outpatient function and subject&#xD;
        usability. The system will then be used by the subjects for the duration of the study always&#xD;
        with the direct supervision of a trained Clinical Research Coordinators.&#xD;
  &#xD;
        Subjects that met all inclusion and exclusion criteria will be entered into the baseline&#xD;
        phase (Day 1 to Day 7) where subjects will continue to receive their baseline&#xD;
        antihypertensive medications while on standard baseline pacing parameters. Subjects will have&#xD;
        at baseline screening day and day 7, 24-hour Ambulatory BP monitoring (ABPM). On Screening&#xD;
        Day subjects will undergo a 2 D echo to assess ejection fraction, 6-Minute Walk test and a&#xD;
        treadmill using the Modified Bruce Protocol on screening and Day 7. On Day 7, if subject has&#xD;
        &gt;3 lbs. weight loss, or &gt;10 mmHg drop in SBP or &gt;5 mmHg drop in DBP (mean of the past 3&#xD;
        12-hour BP readings at home) or is unable to tolerate at least 3 minutes on the Modified&#xD;
        Bruce Protocol treadmill, or walk at least 225 meters during the 6-Minute Walk test, the&#xD;
        subject will be discontinued from the study. Subjects that continue in the study will be&#xD;
        randomized into two groups (8 subjects in each group), group 1 will use BaroPacing for the&#xD;
        first 3 weeks (day 8 to day 28) and then switch to standard treatment for another 3 weeks&#xD;
        (day 29 to day 49). Group 2 will use standard treatment for the first 3 weeks (day 8 to day&#xD;
        28) and then switch to BaroPacing for another 3 weeks (day 29 to day 49). Total study&#xD;
        duration for a subject will be 7 weeks (49 +/- 5 days).&#xD;
  &#xD;
        At the end of 49 days, the subject will return to the office/clinic, the external system&#xD;
        components will be disconnected, and the subject's pacemaker will be returned to pre-study&#xD;
        parameters.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 26, 2023</start_date>
    <completion_date type="Anticipated">November 6, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 6, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Modified Bruce Protocol treadmill total exercise time</measure>
      <time_frame>At Screening Day, Day 7, Day 28, Day 49</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of Related Serious Adverse events</measure>
      <time_frame>From screening to end of study- Day 49</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>NYHA class position</measure>
      <time_frame>At Screening Day, Day 7, Day 28 and Day 49</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline of the total distance in 6 minutes</measure>
      <time_frame>At Screening Day, Day 7, Day 28, Day 49</time_frame>
      <description>The change from baseline on the 7th day of the total distance in 6 minutes, in meters, that the patient can walk compared to 6 minutes walked on day 28 and 49. Baseline will be compared to both treatment and control. The 6-minute walk test will be performed according to the American Thoracic Society guidelines.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in The Minnesota Living with Heart Failure Questionnaire administered</measure>
      <time_frame>At Screening Day, Day 7, Day 28, Day 49</time_frame>
      <description>The Minnesota Living with Heart Failure Questionnaire is a quality-of-life questionnaire. At every 12-hour interval during the study the subject will be asked on the computer tablet a few questions, asking how much you're the treatment has affected the enrolled subject's life on a scale of 0, 1, 2, 3, 4 or 5. Zero denoting no adverse affect on life and 5 denoting very much adverse affect on life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life questions for measuring changes in sense of well-being during intervals of perceived changes in RA pacing</measure>
      <time_frame>Every 12 hours throughout the 21 day treatment duration.</time_frame>
      <description>It is a 3 point scale, Better=2, same=1 worse=0 reduction of Afib: How many episodes in a 21 day period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic blood pressure change from baseline</measure>
      <time_frame>after 21 days or less of treatment</time_frame>
      <description>At least 5 mmHg drop in systolic blood pressure change from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with a Systolic blood pressure drop</measure>
      <time_frame>at the end of 21 days</time_frame>
      <description>Proportion of subjects with a SBP drop &gt;= 5 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response of Systolic blood pressure after lowering</measure>
      <time_frame>at the end of 21 days</time_frame>
      <description>Duration of response of SBP after lowering &gt;= 5 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drop in diastolic blood pressure change from baseline</measure>
      <time_frame>after 21 days or less of treatment</time_frame>
      <description>At least 3 mmHg drop in diastolic blood pressure change from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with a diastolic blood pressure drop</measure>
      <time_frame>at the end of 21 days</time_frame>
      <description>Proportion of subjects with a DBP drop &gt;= 3 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response of diastolic blood pressure after lowering</measure>
      <time_frame>at the end of 21 days</time_frame>
      <description>Duration of response of DBP after lowering &gt;= 3 mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction in the number of antihypertensive medications</measure>
      <time_frame>at the end of 21 days</time_frame>
      <description>Reduction in the number of antihypertensive medications or a reduction in milligrams of one or more medications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction in atrial fibrillation</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks</time_frame>
      <description>Reduction in atrial fibrillation monitored by telemetry and downloaded to PressurePace™</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of intolerance to increases in right atrial pacing</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks</time_frame>
      <description>Rate of intolerance to increases in right atrial pacing requiring reduction to a prior lower level of right atrial pacing</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Feasibility of real-time closed loop programming of a pacemaker atrial rate based on controlled algorithm.</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks</time_frame>
      <description>real time programming worked=1, did not work=0</description>
    </other_outcome>
    <other_outcome>
      <measure>Feasibility of subject's real-time subjective inputs as a moderator of pacemaker atrial rate function and PressurePace™</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks</time_frame>
      <description>real-time inputs resulted in moderating pacemaker atrial rate worked=1, did not =0</description>
    </other_outcome>
    <other_outcome>
      <measure>Real-time closed-loop performance of commands to regulate atrial rate pacing parameters.</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks</time_frame>
      <description>worked=1, did not work=0</description>
    </other_outcome>
    <other_outcome>
      <measure>Subject's report of changes in sense of well-being during intervals of increased right atrial pacing.</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks</time_frame>
      <description>Reported no change=1, reported change to un-well =0</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective inputs by the subject on how he/she is feeling</measure>
      <time_frame>every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks</time_frame>
      <description>Reported yes=1 reported no=0</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Heart Failure With Preserved Ejection Fraction (HFpEF)</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>BaroPacing treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 will use BaroPacing for the first 3 weeks (day 8 to day 28) and then switch to standard treatment for another 3 weeks (day 29 to day 49).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 2 will use standard treatment for the first 3 weeks (day 8 to day 28) and then switch to BaroPacing for another 3 weeks (day 29 to day 49).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>BaroPacing treatment</intervention_name>
      <description>BaroPacing for the first 3 weeks (day 8 to day 28) and then crossover to standard treatment for another 3 weeks (day 29 to day 49).</description>
      <arm_group_label>BaroPacing treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard treatment</intervention_name>
      <description>Individual Standard treatment as prescribed by the Physician to each subject for the first 3 weeks (day 8 to day 28) and then crossover to BaroPacing for another 3 weeks (day 29 to day 49).</description>
      <arm_group_label>Standard treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Have a Pacetronix dual chamber pacemaker implanted for &gt; 2 weeks that is more than 6&#xD;
               months from ERI (elective replacement indicator).&#xD;
  &#xD;
            2. Ages: Adult subjects &gt; 35 years and &lt; 90 of age.&#xD;
  &#xD;
            3. Have heart failure with preserved ejection fraction defined as ejection fraction &gt; 45&#xD;
               percent.&#xD;
  &#xD;
            4. Have hypertension (SBP &gt;135 mmHg) within 30 days before the start of screening,&#xD;
               despite at least one or more medication for the treatment of hypertension.&#xD;
  &#xD;
            5. Screening average right atrial pacing &lt; 50% and average intrinsic/pacing heart rate &lt;&#xD;
               70 bpm over the previous clinical monitoring period of the pacemaker diagnostics of at&#xD;
               least 14 days&#xD;
  &#xD;
            6. Blood pressure of no less than 135 systolic and a diastolic blood pressure no less&#xD;
               than 85 mm Hg at initial screening over 3 readings in 30 minutes in the sitting&#xD;
               position, in the left arm.&#xD;
  &#xD;
            7. Able to tolerate at least 3 minutes of a Modified Bruce Protocol Treadmill&#xD;
  &#xD;
            8. Physically capable and willing to perform repeated 6-minute walk tests associated with&#xD;
               the study, and a baseline distance of at least 225 meters. Symptoms limiting the&#xD;
               duration of the 6-minute walk test must be due to heart failure alone.&#xD;
  &#xD;
            9. Willing and able to sign consent.&#xD;
  &#xD;
           10. Stable medications for Hypertension for at least 4 weeks prior to screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. A resting SBP &gt; 170 mmHg, or &lt; 130 SBP at screening average over 3 readings in 30&#xD;
               minutes. The readings will be taken with the blood pressure cuff on the subject's left&#xD;
               arm while seated after at least ten minutes of rest. Consecutive readings will be&#xD;
               taken at least 10 minutes apart.&#xD;
  &#xD;
            2. A resting DBP &gt; 120 mmHg, or &lt; 80 at screening average over 3 measurements in 30&#xD;
               minutes.&#xD;
  &#xD;
            3. Physical or psychological condition which would impair study participation.&#xD;
  &#xD;
            4. End Stage Renal Disease on haemodialysis&#xD;
  &#xD;
            5. Indications for emergency surgery at time of screening or planned surgery before the&#xD;
               49-day follow-up&#xD;
  &#xD;
            6. Pregnant or breast-feeding.&#xD;
  &#xD;
            7. Hospitalized in the prior six months for a heart attack, stroke, or TIA, or have a&#xD;
               history of blood-pressure related syncope in last 6 months.&#xD;
  &#xD;
            8. Have a pacemaker that is currently the subject of a manufacturer's recall or&#xD;
               regulatory advisory of malfunction.&#xD;
  &#xD;
            9. Prone to atrial or ventricular arrhythmias with altered pacing.&#xD;
  &#xD;
           10. Unstable from a cardiovascular standpoint, such as on-going chest pain, the diagnosis&#xD;
               of heart failure with reduced EF, or who report being ill or otherwise uncomfortable,&#xD;
               medically, or psychologically at the time of study.&#xD;
  &#xD;
           11. Unable to interact and execute commands with the BaroPace modules during the screening&#xD;
               phase.&#xD;
  &#xD;
           12. Taking short acting Nifedipine or Clonidine or taking ISA Beta Blockers; Acebutolol,&#xD;
               Pindolol, Sectral or Visken&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr. Jayashri Krishnan, MD</last_name>
      <phone>(+91) 9771407484</phone>
      <email>jayashri.krishnan@jssresearch.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Maharaja Agrasen Superspeciality Hospital, Clinical Research Department, Basement, Main Building, Room No-09, Sector-07, Agrasen Aspatal Marg, Central Spine, Vidyadhar Nagar,</name>
        <address>
          <city>Jaipur</city>
          <state>Rajasthan</state>
          <zip>302039</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Sanjay Kumar Sharma, MD, DM (Cardiology)</last_name>
        <phone>(+91) 9461011234</phone>
        <email>sanjaysharma.clinical@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dr. C. M. Chopra Hospital &amp; Heart Care Centre</name>
        <address>
          <city>Jaipur</city>
          <state>Rajasthan</state>
          <zip>303702</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Rohit Chopra, DM Cardiology</last_name>
        <phone>(+91) 8867137737</phone>
        <email>drrc2306@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>L.P.S. Institute of Cardiology, G.S.V.M Medical College</name>
        <address>
          <city>Kanpur</city>
          <state>Uttar Pradesh</state>
          <zip>208002</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Santosh Kumar Sinha, DM (Cardiology)</last_name>
        <phone>(+91) 9670220088</phone>
        <email>fionasan@rediffmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036186
  org study id: BP011
  nct id: NCT06036186
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study is a prospective, double blind, self-controlled, randomized, cross-over study to
        evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with
        preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePace™
        system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber
        pacemakers.
  
        The objective of this study is to show that blood pressure-controlled right atrial pacing
        improves exercise tolerance, improves heart failure symptoms, and improves hypertension
        control in subjects with HFpEF associated with hypertension compared to conventional
        bradycardia pacing alone.
  This study is a prospective, double blind, self-controlled, randomized, cross-over study to
        evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with
        preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePace™
        system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber
        pacemakers. No surgery, intervention or implant will occur during this study. All subjects
        enrolled in the study already have a dual chamber pacemaker implanted for standard clinical
        indications.
  
        The objective of this study is to show that blood pressure-controlled right atrial pacing
        improves exercise tolerance, improves heart failure symptoms and improves hypertension
        control in subjects with HFpEF associated with hypertension compared to conventional
        bradycardia pacing alone.
  
        Each subject will have an office/clinic visit. Once the subject signs informed consent, the
        pacemaker will be interrogated by trained personnel. If all the inclusion/exclusion criteria
        are met, then the pacemaker will be connected to the pacemaker manufacturer's interrogation
        module which will be connected to the BaroPace interface. The system will run with clinical
        oversight in the office to determine suitability for outpatient function and subject
        usability. The system will then be used by the subjects for the duration of the study always
        with the direct supervision of a trained Clinical Research Coordinators.
  
        Subjects that met all inclusion and exclusion criteria will be entered into the baseline
        phase (Day 1 to Day 7) where subjects will continue to receive their baseline
        antihypertensive medications while on standard baseline pacing parameters. Subjects will have
        at baseline screening day and day 7, 24-hour Ambulatory BP monitoring (ABPM). On Screening
        Day subjects will undergo a 2 D echo to assess ejection fraction, 6-Minute Walk test and a
        treadmill using the Modified Bruce Protocol on screening and Day 7. On Day 7, if subject has
        >3 lbs. weight loss, or >10 mmHg drop in SBP or >5 mmHg drop in DBP (mean of the past 3
        12-hour BP readings at home) or is unable to tolerate at least 3 minutes on the Modified
        Bruce Protocol treadmill, or walk at least 225 meters during the 6-Minute Walk test, the
        subject will be discontinued from the study. Subjects that continue in the study will be
        randomized into two groups (8 subjects in each group), group 1 will use BaroPacing for the
        first 3 weeks (day 8 to day 28) and then switch to standard treatment for another 3 weeks
        (day 29 to day 49). Group 2 will use standard treatment for the first 3 weeks (day 8 to day
        28) and then switch to BaroPacing for another 3 weeks (day 29 to day 49). Total study
        duration for a subject will be 7 weeks (49 +/- 5 days).
  
        At the end of 49 days, the subject will return to the office/clinic, the external system
        components will be disconnected, and the subject's pacemaker will be returned to pre-study
        parameters.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Modified Bruce Protocol treadmill total exercise time
  time frame: At Screening Day, Day 7, Day 28, Day 49
  measure: Absence of Related Serious Adverse events
  time frame: From screening to end of study- Day 49
  measure: NYHA class position
  time frame: At Screening Day, Day 7, Day 28 and Day 49
  measure: Change from baseline of the total distance in 6 minutes
  time frame: At Screening Day, Day 7, Day 28, Day 49
  description: The change from baseline on the 7th day of the total distance in 6 minutes, in meters, that the patient can walk compared to 6 minutes walked on day 28 and 49. Baseline will be compared to both treatment and control. The 6-minute walk test will be performed according to the American Thoracic Society guidelines.
  measure: Changes in The Minnesota Living with Heart Failure Questionnaire administered
  time frame: At Screening Day, Day 7, Day 28, Day 49
  description: The Minnesota Living with Heart Failure Questionnaire is a quality-of-life questionnaire. At every 12-hour interval during the study the subject will be asked on the computer tablet a few questions, asking how much you're the treatment has affected the enrolled subject's life on a scale of 0, 1, 2, 3, 4 or 5. Zero denoting no adverse affect on life and 5 denoting very much adverse affect on life.
  measure: Quality of life questions for measuring changes in sense of well-being during intervals of perceived changes in RA pacing
  time frame: Every 12 hours throughout the 21 day treatment duration.
  description: It is a 3 point scale, Better=2, same=1 worse=0 reduction of Afib: How many episodes in a 21 day period.
  measure: Systolic blood pressure change from baseline
  time frame: after 21 days or less of treatment
  description: At least 5 mmHg drop in systolic blood pressure change from baseline
  measure: Proportion of subjects with a Systolic blood pressure drop
  time frame: at the end of 21 days
  description: Proportion of subjects with a SBP drop >= 5 mmHg
  measure: Duration of response of Systolic blood pressure after lowering
  time frame: at the end of 21 days
  description: Duration of response of SBP after lowering >= 5 mmHg
  measure: Drop in diastolic blood pressure change from baseline
  time frame: after 21 days or less of treatment
  description: At least 3 mmHg drop in diastolic blood pressure change from baseline
  measure: Proportion of subjects with a diastolic blood pressure drop
  time frame: at the end of 21 days
  description: Proportion of subjects with a DBP drop >= 3 mmHg
  measure: Duration of response of diastolic blood pressure after lowering
  time frame: at the end of 21 days
  description: Duration of response of DBP after lowering >= 3 mmHg
  measure: Reduction in the number of antihypertensive medications
  time frame: at the end of 21 days
  description: Reduction in the number of antihypertensive medications or a reduction in milligrams of one or more medications
  measure: Reduction in atrial fibrillation
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks
  description: Reduction in atrial fibrillation monitored by telemetry and downloaded to PressurePace™
  measure: Rate of intolerance to increases in right atrial pacing
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks
  description: Rate of intolerance to increases in right atrial pacing requiring reduction to a prior lower level of right atrial pacing
  measure: Feasibility of real-time closed loop programming of a pacemaker atrial rate based on controlled algorithm.
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks
  description: real time programming worked=1, did not work=0
  measure: Feasibility of subject's real-time subjective inputs as a moderator of pacemaker atrial rate function and PressurePace™
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks
  description: real-time inputs resulted in moderating pacemaker atrial rate worked=1, did not =0
  measure: Real-time closed-loop performance of commands to regulate atrial rate pacing parameters.
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks
  description: worked=1, did not work=0
  measure: Subject's report of changes in sense of well-being during intervals of increased right atrial pacing.
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks
  description: Reported no change=1, reported change to un-well =0
  measure: Subjective inputs by the subject on how he/she is feeling
  time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks
  description: Reported yes=1 reported no=0
  arm group label: BaroPacing treatment
  arm group type: Experimental
  description: Group 1 will use BaroPacing for the first 3 weeks (day 8 to day 28) and then switch to standard treatment for another 3 weeks (day 29 to day 49).
  arm group label: Standard treatment
  arm group type: Active Comparator
  description: Group 2 will use standard treatment for the first 3 weeks (day 8 to day 28) and then switch to BaroPacing for another 3 weeks (day 29 to day 49).
  intervention type: Device
  intervention name: BaroPacing treatment
  description: BaroPacing for the first 3 weeks (day 8 to day 28) and then crossover to standard treatment for another 3 weeks (day 29 to day 49).
  arm group label: BaroPacing treatment
  intervention type: Device
  intervention name: Standard treatment
  description: Individual Standard treatment as prescribed by the Physician to each subject for the first 3 weeks (day 8 to day 28) and then crossover to BaroPacing for another 3 weeks (day 29 to day 49).
  arm group label: Standard treatment
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Dr. Jayashri Krishnan, MD
  phone: (+91) 9771407484
  email: jayashri.krishnan@jssresearch.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Heart Failure
  sharing ipd: No