<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/NCT03016975</url>
  </required_header>
  <id_info>
    <org_study_id>2017-05</org_study_id>
    <nct_id>NCT03016975</nct_id>
  </id_info>
  <brief_title>Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)</brief_title>
  <acronym>ACTIVE</acronym>
  <official_title>Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish the safety and effectiveness of the Edwards Cardioband System in patients with&#xD;
      functional mitral regurgitation (FMR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically&#xD;
      significant functional mitral regurgitation will be randomized 2:1 to receive either&#xD;
      transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed&#xD;
      medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at&#xD;
      discharge, 30 days, 6 months, and annually through 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Actual">July 19, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].</measure>
    <time_frame>1 year</time_frame>
    <description>Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Major Adverse Events (MAE) [Device Group Only]</measure>
    <time_frame>30 days</time_frame>
    <description>Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Safety Endpoints [Device Group Only]</measure>
    <time_frame>30 days</time_frame>
    <description>Components will be calculated with 95% confidence intervals&#xD;
Death&#xD;
Stroke&#xD;
Myocardial infarction&#xD;
Pericardial effusion requiring drainage&#xD;
Mitral valve reintervention&#xD;
Access site and vascular complications requiring intervention&#xD;
Left circumflex coronary artery injury requiring intervention&#xD;
Need for a new permanent pacemaker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)</measure>
    <time_frame>1 year</time_frame>
    <description>The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power.&#xD;
MR ≤ 1+&#xD;
NYHA Class&#xD;
Kansas City Cardiomyopathy Questionnaire (KCCQ)&#xD;
6 Minute Walk Test (6MWT)&#xD;
SF-36v2 Health Survey (SF-36)&#xD;
Heart Failure Hospitalizations&#xD;
Cardiovascular mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Success</measure>
    <time_frame>30 days</time_frame>
    <description>Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural Success</measure>
    <time_frame>30 days</time_frame>
    <description>Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>30 days</time_frame>
    <description>Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs* at 30 days (per patient analysis).&#xD;
*Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Functional Mitral Regurgitation</condition>
  <condition>Mitral Regurgitation</condition>
  <condition>Mitral Insufficiency</condition>
  <arm_group>
    <arm_group_label>Randomized - Edwards Cardioband System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomized - Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Guideline directed medical therapy (GDMT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Roll-In - Edwards Cardioband System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards Cardioband System</intervention_name>
    <description>Transcatheter mitral valve repair with the Edwards Cardioband System</description>
    <arm_group_label>Randomized - Edwards Cardioband System</arm_group_label>
    <arm_group_label>Roll-In - Edwards Cardioband System</arm_group_label>
    <other_name>Transcatheter mitral valve repair (TMVr)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guideline Directed Medical Therapy</intervention_name>
    <description>GDMT Only</description>
    <arm_group_label>Randomized - Control</arm_group_label>
    <arm_group_label>Randomized - Edwards Cardioband System</arm_group_label>
    <arm_group_label>Roll-In - Edwards Cardioband System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years;&#xD;
&#xD;
          -  Clinically Significant Functional Mitral Regurgitation (MR);&#xD;
&#xD;
          -  Symptomatic heart failure;&#xD;
&#xD;
          -  Patient hospitalized due to heart failure during 12 months prior to submission to&#xD;
             Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);&#xD;
&#xD;
          -  Patient is able and willing to give informed consent and follow protocol procedures,&#xD;
             and comply with follow-up visit compliance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primarily degenerative MR;&#xD;
&#xD;
          -  Mitral annular calcification that would impede implantation of device;&#xD;
&#xD;
          -  Other severe valve disorders requiring intervention;&#xD;
&#xD;
          -  Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;&#xD;
&#xD;
          -  Life expectancy of less than twelve months;&#xD;
&#xD;
          -  Patient is participating in concomitant research studies of investigational products&#xD;
             which have not reached their primary endpoint;&#xD;
&#xD;
          -  Unwillingness or inability to undergo follow-up investigations/visits;&#xD;
&#xD;
          -  Other medical, social, or psychological conditions that precludes appropriate consent&#xD;
             and follow-up&#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>Brian Whisenant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vinod Thourani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Piedmont Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Heart Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital - Northwell Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Hospital</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanger Heart &amp; Vascular Institute - Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health &amp;Services, Heart &amp; Vascular Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>April 13, 2022</results_first_submitted>
  <results_first_submitted_qc>October 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2022</results_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Edwards Cardioband</keyword>
  <keyword>Mitral Valve</keyword>
  <keyword>Transcatheter</keyword>
  <keyword>Mitral repair</keyword>
  <keyword>Functional mitral regurgitation</keyword>
  <keyword>Secondary mitral regurgitation</keyword>
  <keyword>Annuloplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03016975/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03016975/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Roll-in</title>
          <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT).&#xD;
This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
        </group>
        <group group_id="P2">
          <title>Experimental: Edwards Cardioband System</title>
          <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
        </group>
        <group group_id="P3">
          <title>Control: No Intervention</title>
          <description>Guideline directed medical therapy (GDMT)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>At 30 Days Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subject is a Screen failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>At 6 Months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject withdrawn by investigator</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Re-attempt procedure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Aborted implant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>At 1 Year Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>At 2 Year Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>At 3 Year Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data were not collected for the experimental or control group.</population>
      <group_list>
        <group group_id="B1">
          <title>Roll-in</title>
          <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT).&#xD;
This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
        </group>
        <group group_id="B2">
          <title>Experimental: Edwards Cardioband System</title>
          <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
        </group>
        <group group_id="B3">
          <title>Control: No Intervention</title>
          <description>Guideline directed medical therapy (GDMT)</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="12"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="12"/>
          </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="12"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.8" spread="9.60"/>
                    <measurement group_id="B4" value="71.8" spread="9.60"/>
                  </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="12"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Data unavailable for 3 patients</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="9"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NYHA Functional Class</title>
          <description>Measure Description:&#xD;
NYHA Classification - The stages of heart failure:&#xD;
Class I - No symptoms and no limitation in ordinary physical activity&#xD;
Class II - Mild symptoms and slight limitation during ordinary activity.&#xD;
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.&#xD;
Class IV - Severe limitations. Experiences symptoms even while at rest</description>
          <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="12"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Class 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].</title>
        <description>Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).</description>
        <time_frame>1 year</time_frame>
        <population>No patients were randomized, therefore no data was collected. This parameter is meant to be analyzed in hierarchical order for the randomized arms only.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O2">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].</title>
          <description>Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).</description>
          <population>No patients were randomized, therefore no data was collected. This parameter is meant to be analyzed in hierarchical order for the randomized arms only.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Major Adverse Events (MAE) [Device Group Only]</title>
        <description>Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention</description>
        <time_frame>30 days</time_frame>
        <population>No patients were randomized, therefore no data was collected in the randomized phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Roll-in</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O3">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Adverse Events (MAE) [Device Group Only]</title>
          <description>Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention</description>
          <population>No patients were randomized, therefore no data was collected in the randomized phase.</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="8"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Safety Endpoints [Device Group Only]</title>
        <description>Components will be calculated with 95% confidence intervals&#xD;
Death&#xD;
Stroke&#xD;
Myocardial infarction&#xD;
Pericardial effusion requiring drainage&#xD;
Mitral valve reintervention&#xD;
Access site and vascular complications requiring intervention&#xD;
Left circumflex coronary artery injury requiring intervention&#xD;
Need for a new permanent pacemaker</description>
        <time_frame>30 days</time_frame>
        <population>No patients were randomized, therefore no data was collected</population>
        <group_list>
          <group group_id="O1">
            <title>Roll-in</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O3">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Safety Endpoints [Device Group Only]</title>
          <description>Components will be calculated with 95% confidence intervals&#xD;
Death&#xD;
Stroke&#xD;
Myocardial infarction&#xD;
Pericardial effusion requiring drainage&#xD;
Mitral valve reintervention&#xD;
Access site and vascular complications requiring intervention&#xD;
Left circumflex coronary artery injury requiring intervention&#xD;
Need for a new permanent pacemaker</description>
          <population>No patients were randomized, therefore no data was collected</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="8"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)</title>
        <description>The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power.&#xD;
MR ≤ 1+&#xD;
NYHA Class&#xD;
Kansas City Cardiomyopathy Questionnaire (KCCQ)&#xD;
6 Minute Walk Test (6MWT)&#xD;
SF-36v2 Health Survey (SF-36)&#xD;
Heart Failure Hospitalizations&#xD;
Cardiovascular mortality</description>
        <time_frame>1 year</time_frame>
        <population>No patients were randomized, therefore no data was collected. The parameter is meant to be analyzed in hierarchical order for the randomized arms only.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O2">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)</title>
          <description>The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power.&#xD;
MR ≤ 1+&#xD;
NYHA Class&#xD;
Kansas City Cardiomyopathy Questionnaire (KCCQ)&#xD;
6 Minute Walk Test (6MWT)&#xD;
SF-36v2 Health Survey (SF-36)&#xD;
Heart Failure Hospitalizations&#xD;
Cardiovascular mortality</description>
          <population>No patients were randomized, therefore no data was collected. The parameter is meant to be analyzed in hierarchical order for the randomized arms only.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device Success</title>
        <description>Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis).</description>
        <time_frame>30 days</time_frame>
        <population>No patients were randomized, therefore no data was collected in the randomized phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Roll-in</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O3">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Device Success</title>
          <description>Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis).</description>
          <population>No patients were randomized, therefore no data was collected in the randomized phase.</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="12"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedural Success</title>
        <description>Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis).</description>
        <time_frame>30 days</time_frame>
        <population>No patients were randomized, therefore no data was collected in the randomized phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Roll-in</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O3">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Success</title>
          <description>Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis).</description>
          <population>No patients were randomized, therefore no data was collected in the randomized phase.</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="12"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Success</title>
        <description>Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs* at 30 days (per patient analysis).&#xD;
*Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention.</description>
        <time_frame>30 days</time_frame>
        <population>No patients were randomized, therefore no data was collected in the randomized phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Roll-in</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Edwards Cardioband System</title>
            <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)</description>
          </group>
          <group group_id="O3">
            <title>Control: No Intervention</title>
            <description>Guideline directed medical therapy (GDMT)</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Success</title>
          <description>Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs* at 30 days (per patient analysis).&#xD;
*Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention.</description>
          <population>No patients were randomized, therefore no data was collected in the randomized phase.</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="12"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 Years</time_frame>
      <desc>Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups</desc>
      <group_list>
        <group group_id="E1">
          <title>Roll-in</title>
          <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT).&#xD;
This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.</description>
        </group>
        <group group_id="E2">
          <title>Experimental: Edwards Cardioband System</title>
          <description>Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT).</description>
        </group>
        <group group_id="E3">
          <title>Control: No Intervention</title>
          <description>Guideline directed medical therapy (GDMT)</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Left Ventricular Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" events="12" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium Difficile Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Aortic Perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Clavicle Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Prostatic Specific Antigen Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="7" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block First Degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nodal Rhythm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Supraventricular Extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Tricuspid Valve Incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rectal Abcess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Medical Device Site Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram Qt Prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Troponin I Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Air Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </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 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>Ted Feldman</name_or_title>
      <organization>Edwards Lifesciences</organization>
      <phone>949-250-2500</phone>
      <email>Feldman_Info@edwards.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/NCT03016975
org study id: 2017-05
nct id: NCT03016975
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To establish the safety and effectiveness of the Edwards Cardioband System in patients with
      functional mitral regurgitation (FMR).
The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically
      significant functional mitral regurgitation will be randomized 2:1 to receive either
      transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed
      medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at
      discharge, 30 days, 6 months, and annually through 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].
time frame: 1 year
description: Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).
measure: Number of Participants With Major Adverse Events (MAE) [Device Group Only]
time frame: 30 days
description: Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention
measure: Secondary Safety Endpoints [Device Group Only]
time frame: 30 days
description: Components will be calculated with 95% confidence intervals
Death
Stroke
Myocardial infarction
Pericardial effusion requiring drainage
Mitral valve reintervention
Access site and vascular complications requiring intervention
Left circumflex coronary artery injury requiring intervention
Need for a new permanent pacemaker
measure: Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)
time frame: 1 year
description: The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power.
MR ≤ 1+
NYHA Class
Kansas City Cardiomyopathy Questionnaire (KCCQ)
6 Minute Walk Test (6MWT)
SF-36v2 Health Survey (SF-36)
Heart Failure Hospitalizations
Cardiovascular mortality
measure: Device Success
time frame: 30 days
description: Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis).
measure: Procedural Success
time frame: 30 days
description: Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis).
measure: Clinical Success
time frame: 30 days
description: Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs* at 30 days (per patient analysis).
*Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention.
arm group label: Randomized - Edwards Cardioband System
arm group type: Experimental
description: Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
arm group label: Randomized - Control
arm group type: Active Comparator
description: Guideline directed medical therapy (GDMT)
arm group label: Roll-In - Edwards Cardioband System
arm group type: Experimental
description: Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
intervention type: Device
intervention name: Edwards Cardioband System
description: Transcatheter mitral valve repair with the Edwards Cardioband System
arm group label: Randomized - Edwards Cardioband System
arm group label: Roll-In - Edwards Cardioband System
other name: Transcatheter mitral valve repair (TMVr)
intervention type: Drug
intervention name: Guideline Directed Medical Therapy
description: GDMT Only
arm group label: Randomized - Control
arm group label: Randomized - Edwards Cardioband System
arm group label: Roll-In - Edwards Cardioband System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Whisenant, MD
role: Principal Investigator
affiliation: Intermountain Medical Center
last name: Vinod Thourani, MD
role: Principal Investigator
affiliation: Piedmont Heart Institute
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country: United States
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: Undecided
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