<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/NCT01699529</url>
  </required_header>
  <id_info>
    <org_study_id>10058715DOC</org_study_id>
    <nct_id>NCT01699529</nct_id>
  </id_info>
  <brief_title>Multi-electrode Radiofrequency Renal Denervation System Feasibility Study</brief_title>
  <official_title>Multi-electrode Radiofrequency Renal Denervation System Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Vascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Vascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, single-arm, non-randomized and open label feasibility study. The study&#xD;
      is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal&#xD;
      denervation in patients with uncontrolled hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute safety as measured by procedural complications</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Office Systolic Blood Pressure</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Uncontrolled Hypertension</condition>
  <arm_group>
    <arm_group_label>Renal Denervation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system</intervention_name>
    <description>The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.</description>
    <arm_group_label>Renal Denervation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual is ≥ 18 and ≤ 80 years old.&#xD;
&#xD;
          -  Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg&#xD;
             for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings&#xD;
&#xD;
          -  Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive&#xD;
             medications(preferred that one is a diuretic) for a minimum of two weeks prior to&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual has an estimated glomerular filtration rate (eGFR) of &lt; 45 mL/min/1.73 m2&#xD;
&#xD;
          -  Individual has type 1 diabetes mellitus&#xD;
&#xD;
          -  Individual requires chronic oxygen support or mechanical ventilation (e.g.,&#xD;
             tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.&#xD;
&#xD;
          -  Individual has primary pulmonary hypertension.&#xD;
&#xD;
          -  Individual is pregnant, nursing or planning to be pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Whitbourn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Vincent's Hospital Melbourne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital Melbourne</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epworth Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3069</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</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>
  </condition_browse>
  <!-- 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/NCT01699529
org study id: 10058715DOC
nct id: NCT01699529
lead sponsor: 
has dmc: Yes
This is a prospective, single-arm, non-randomized and open label feasibility study. The study
      is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal
      denervation in patients with uncontrolled hypertension.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute safety as measured by procedural complications
time frame: 1 month
measure: Change in Office Systolic Blood Pressure
time frame: Baseline to 6 months
arm group label: Renal Denervation
arm group type: Experimental
intervention type: Device
intervention name: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
description: The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
arm group label: Renal Denervation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Robert Whitbourn, MD
role: Principal Investigator
affiliation: St Vincent's Hospital Melbourne
facility: 
facility: 
facility: 
facility: 
country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Hypertension