<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/NCT03261375</url>
  </required_header>
  <id_info>
    <org_study_id>MLWY-SXX201601</org_study_id>
    <nct_id>NCT03261375</nct_id>
  </id_info>
  <brief_title>To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension</brief_title>
  <official_title>Prospective Multicenter Randomized Parallel Controlled Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Renal Denervation System for the Treatment of Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Golden Leaf MedTec Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Golden Leaf MedTec Co. Ltd</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and&#xD;
      efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in&#xD;
      treating patients with uncontrolled essential hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, randomized sham-controlled trial. Patients with&#xD;
      uncontrolled hypertension (office BP ≥150/90 and &lt;180/110mmHg, and average SBP ≥135mmHg by&#xD;
      24-hour ambulatory BP monitoring (ABPM), after taking ≥2 antihypertensive drugs with stable&#xD;
      dose for ≥ 4 weeks) were screened after informed consent. All eligible patients first entered&#xD;
      a lead-in period for ≥4 weeks of standardized medication (Nifedipine + hydrochlorothiazide),&#xD;
      and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to&#xD;
      RDN group and sham control group (renal artery angiography only). All continued with the&#xD;
      2-drug regimen and were evaluated at 7, 30, 60, 90 and 180 days post procedure. Both patients&#xD;
      and site investigators who evaluate the patients were blinded to treatment assignment. The&#xD;
      primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary&#xD;
      endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post&#xD;
      procedure and safety events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2021</start_date>
  <completion_date type="Actual">December 26, 2022</completion_date>
  <primary_completion_date type="Actual">December 26, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Both patients and site investigators who evaluate the patients were blinded to treatment assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Office SBP change from baseline at 6 months post procedure</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Change in office blood systolic pressure (SBP) at 6 months post procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Office DBP change from baseline at 6 months post procedure</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Change in office blood diastolic pressure (DBP) at 6 months post procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 24-hour ambulatory BP at 6 months post procedure</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Changes in 24-hour ambulatory SBP and DBP from baseline at 6 months post procedure measured by 24-hour ABPM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of achieving target office SBP (90mmHg≤SBP&lt;140mmHg) at 6 months post procedure</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Patient proportion of achieving target office SBP (90mmHg≤SBP&lt;140mmHg) at 6 months post index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of major adverse events (MAE) through 6 months post index procedure</measure>
    <time_frame>From index procedure to 6 months post procedure</time_frame>
    <description>The rate of major adverse events (MAE) through 6 months post index procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Renal denervation (RDN) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Renal Artery Radiofrequency Ablation System (Generator and Catheter )</intervention_name>
    <description>A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator</description>
    <arm_group_label>Renal denervation (RDN) Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antihypertensive Agents</intervention_name>
    <description>Calcium channel blocker, Diuretic</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Renal denervation (RDN) Group</arm_group_label>
    <other_name>Nifedipine and hydrochlorothiazide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Procedure</intervention_name>
    <description>Catheterization without renal denervation</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with age of 18 to 65 years old (include 65), male or female;&#xD;
&#xD;
          2. Subject with essential hypertension who has an office BP of ≥150/90mmHg and &lt;180/110&#xD;
             mmHg (both SBP and DBP meet the criteria), and an average SBP of ≥ 135mmHg measured by&#xD;
             24-hour ABPM, after taking ≥ 2 antihypertensive medications for ≥ 4 weeks;&#xD;
&#xD;
          3. Subject with the resting heart rate ≥70bpm, if not taking beta-blockers (this&#xD;
             criterion does not apply to those taking beta-blockers);&#xD;
&#xD;
          4. Subject with confirmed diagnosis of essential hypertension;&#xD;
&#xD;
          5. Subject with or without accessary renal arteries;&#xD;
&#xD;
          6. Subject who has signed the informed consent form, agrees to participate in this&#xD;
             clinical trial, and is willing to comply with the required follow-ups per the trial&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject who is pregnant, nursing or planning to become pregnant during the study;&#xD;
&#xD;
          2. Subject with the shape and structure of unilateral or bilateral renal artery that are&#xD;
             not suitable for ablation procedure (renal artery stenosis more than 50%, renal&#xD;
             aneurysm, renal artery abnormality, renal artery diameter &lt;4mm or treatable segment&#xD;
             length &lt;20mm);&#xD;
&#xD;
          3. Subject who has unilateral kidney or kidney transplant;&#xD;
&#xD;
          4. Subject with a history of renal artery interventional therapy or renal denervation;&#xD;
&#xD;
          5. Subject with any conditions that may affect the accuracy of blood pressure&#xD;
             measurement: such as the diameter of the upper arm is too large relative to the cuff,&#xD;
             arrhythmia;&#xD;
&#xD;
          6. Subject with secondary hypertension;&#xD;
&#xD;
          7. Subject with pseudo-hypertension;&#xD;
&#xD;
          8. Subject with orthostatic hypotension;&#xD;
&#xD;
          9. Subject with eGFR &lt;45mL/min/l.73m2;&#xD;
&#xD;
         10. Subject with average SBP is &lt; 135mmHg on 24-hour ABPM;&#xD;
&#xD;
         11. Subject with a history of hospitalization for hypertensive emergency within past one&#xD;
             year;&#xD;
&#xD;
         12. Subject with type I diabetes mellitus;&#xD;
&#xD;
         13. Subject with primary pulmonary hypertension;&#xD;
&#xD;
         14. Subject with a history of bleeding diathesis and hematological disorders;&#xD;
&#xD;
         15. Subject with a history of embolism within past 6 months;&#xD;
&#xD;
         16. Subject with a history of acute coronary syndrome within past 6 months;&#xD;
&#xD;
         17. Subject with a history of ventricular fibrillation, polymorphic ventricular&#xD;
             tachycardia within past 6 months;&#xD;
&#xD;
         18. Subject with serum HIV-positive;&#xD;
&#xD;
         19. Subject who is allergic to contrast agents;&#xD;
&#xD;
         20. Subject with mental illness or any psychological problems that may interfere with the&#xD;
             participating in the study;&#xD;
&#xD;
         21. Subject with a history of stroke or transient ischemic attack (TIA) within past 3&#xD;
             months;&#xD;
&#xD;
         22. Subject with malignant tumors or end-stage disease;&#xD;
&#xD;
         23. Subject with severe peripheral vascular disease or abdominal aortic aneurysm;&#xD;
&#xD;
         24. Subject with severe heart valve stenosis;&#xD;
&#xD;
         25. Subject with cardiac insufficiency (NYHA class III~IV);&#xD;
&#xD;
         26. Subject with hyperthyroidism or hypothyroidism;&#xD;
&#xD;
         27. Subject with severe electrolyte or liver function abnormalities;&#xD;
&#xD;
         28. Subject who requires mechanical ventilation other than nocturnal respiratory support&#xD;
             for sleep apnea;&#xD;
&#xD;
         29. Subject with acute or severe systemic infection;&#xD;
&#xD;
         30. Subject with a history of pacemaker implantation;&#xD;
&#xD;
         31. Subject with a history of major surgery or trauma within 30 days prior to enrollment;&#xD;
&#xD;
         32. Subject who has planned surgery or cardiovascular intervention within the next 6&#xD;
             months;&#xD;
&#xD;
         33. Subject who is participating in other drug or medical device clinical trials;&#xD;
&#xD;
         34. Subject who has known drug or alcohol dependence, difficulty to understand the trial&#xD;
             protocol, inability/unwillingness to follow the trial protocol;&#xD;
&#xD;
         35. Subject who is unsuitable for participating in this study in the opinion of&#xD;
             investigators;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yujie Zhou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shijiazhuang People's Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanyang Second People's Hospital</name>
      <address>
        <city>Nanyang</city>
        <state>Henan</state>
        <zip>473009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Seventh People's Hospital of Zhengzhou</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 1st Affiliated Hospital Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital, Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heze Municipal Hospital</name>
      <address>
        <city>Heze</city>
        <state>Shandong</state>
        <zip>274099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Jining, Shandong Province</name>
      <address>
        <city>Jining</city>
        <state>Shandong</state>
        <zip>272002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qingdao Central Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shangdong</state>
        <zip>266042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai First People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200940</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Bethune Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>100005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xianyang Hospital of Yan 'an University</name>
      <address>
        <city>Yanan</city>
        <state>Shanxi</state>
        <zip>716099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuncheng Central Hospital</name>
      <address>
        <city>Yuncheng</city>
        <state>Shanxi</state>
        <zip>044099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huaxi Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <zip>830011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinjiang Autonomous Region People's Hospital</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <zip>830011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Run Run Shaw Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>January 2, 2023</last_update_submitted>
  <last_update_submitted_qc>January 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Renal Denervation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Antihypertensive Agents</mesh_term>
    <mesh_term>Nifedipine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 27, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03261375
org study id: MLWY-SXX201601
nct id: NCT03261375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and
      efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in
      treating patients with uncontrolled essential hypertension.
This is a prospective, multicenter, randomized sham-controlled trial. Patients with
      uncontrolled hypertension (office BP ≥150/90 and <180/110mmHg, and average SBP ≥135mmHg by
      24-hour ambulatory BP monitoring (ABPM), after taking ≥2 antihypertensive drugs with stable
      dose for ≥ 4 weeks) were screened after informed consent. All eligible patients first entered
      a lead-in period for ≥4 weeks of standardized medication (Nifedipine + hydrochlorothiazide),
      and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to
      RDN group and sham control group (renal artery angiography only). All continued with the
      2-drug regimen and were evaluated at 7, 30, 60, 90 and 180 days post procedure. Both patients
      and site investigators who evaluate the patients were blinded to treatment assignment. The
      primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary
      endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post
      procedure and safety events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Both patients and site investigators who evaluate the patients were blinded to treatment assignment.
measure: Office SBP change from baseline at 6 months post procedure
time frame: From baseline to 6 months
description: Change in office blood systolic pressure (SBP) at 6 months post procedure
measure: Office DBP change from baseline at 6 months post procedure
time frame: From baseline to 6 months
description: Change in office blood diastolic pressure (DBP) at 6 months post procedure
measure: Changes in 24-hour ambulatory BP at 6 months post procedure
time frame: From baseline to 6 months
description: Changes in 24-hour ambulatory SBP and DBP from baseline at 6 months post procedure measured by 24-hour ABPM
measure: Incidence of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post procedure
time frame: From baseline to 6 months
description: Patient proportion of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post index procedure
measure: Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
time frame: From baseline to 6 months
description: Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
measure: The rate of major adverse events (MAE) through 6 months post index procedure
time frame: From index procedure to 6 months post procedure
description: The rate of major adverse events (MAE) through 6 months post index procedure
arm group label: Renal denervation (RDN) Group
arm group type: Experimental
description: Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)
arm group label: Control Group
arm group type: Sham Comparator
description: Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only
intervention type: Device
intervention name: Renal Artery Radiofrequency Ablation System (Generator and Catheter )
description: A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator
arm group label: Renal denervation (RDN) Group
intervention type: Drug
intervention name: Antihypertensive Agents
description: Calcium channel blocker, Diuretic
arm group label: Control Group
arm group label: Renal denervation (RDN) Group
other name: Nifedipine and hydrochlorothiazide
intervention type: Device
intervention name: Sham Procedure
description: Catheterization without renal denervation
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yujie Zhou, MD
role: Principal Investigator
affiliation: Beijing Anzhen Hospital
facility: 
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country: China
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Hydrochlorothiazide
mesh term: Antihypertensive Agents
mesh term: Nifedipine
sharing ipd: No
submitted: June 27, 2023