<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/NCT03271762</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0002</org_study_id>
    <nct_id>NCT03271762</nct_id>
  </id_info>
  <brief_title>Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery</brief_title>
  <acronym>MITRA-HR</acronym>
  <official_title>Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministère de la Santé</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an&#xD;
      endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment&#xD;
      strategy in patients with severe primary mitral regurgitation judged eligible for anatomical&#xD;
      repair with the MitraClip® or mitral valve surgery with high surgical risk.&#xD;
&#xD;
      This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled&#xD;
      will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12&#xD;
      months, phone call at 18 months and clincial visit at 24 months).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2, 2018</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">March 2026</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>All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention</measure>
    <time_frame>12 months</time_frame>
    <description>comparison between arms of:&#xD;
number and reason of death&#xD;
number and reason unplanned rehospitalisation for cardiovascular reasons,&#xD;
number of mitral valve reintervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>occurrence of a major adverse event</measure>
    <time_frame>30 days</time_frame>
    <description>all-cause death, need for non-elective cardiovascular or thoracic surgery, device or procedure-related adverse events, major bleeding complications or serious bleeding, major access site vascular complications, major cardiac structural complications, pulmonary complications (device or procedure-related), stroke and other cerebrovascular events, myocardial infarction, acute kidney injury or progression of chronic kidney disease, arrhythmias and conduction system disturbances, unplanned mitral valve surgery due to device/procedure failure or malfunction, requirement for valve replacement after valve repair failure, unplanned cardiac surgery for any cause</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>SAEs et SADEs rate related to protocol procedure all SAEs and SADEs</description>
  </other_outcome>
  <other_outcome>
    <measure>all-cause mortality</measure>
    <time_frame>30 days and 6, 12 and 24 months</time_frame>
    <description>Rate of global mortality (all-causes)</description>
  </other_outcome>
  <other_outcome>
    <measure>cardiovascular mortality</measure>
    <time_frame>30 days and 6, 12 and 24 months</time_frame>
    <description>Rate of cardiovascular mortality</description>
  </other_outcome>
  <other_outcome>
    <measure>unplanned heart failure rehospitalization</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Rate of unplanned heart failure rehospitalization</description>
  </other_outcome>
  <other_outcome>
    <measure>unplanned rehospitalization rate for cardiovascular reasons</measure>
    <time_frame>30 days 6, 12 and 24 months</time_frame>
    <description>Rate of unplanned rehospitalization for cardiovascular reasons</description>
  </other_outcome>
  <other_outcome>
    <measure>mitral valve reintervention</measure>
    <time_frame>30 days 6, 12 and 24 months</time_frame>
    <description>Mitral valve reintervention rate</description>
  </other_outcome>
  <other_outcome>
    <measure>residual MR</measure>
    <time_frame>30 days 6, 12 and 24 months</time_frame>
    <description>MR (Mitral Regurgitation): grade</description>
  </other_outcome>
  <other_outcome>
    <measure>left and right chamber remodelling and parameters (dimension)</measure>
    <time_frame>baseline, 30 days and 12 months</time_frame>
    <description>End-systolic dimension End-diastolic dimension Left atrial dimension</description>
  </other_outcome>
  <other_outcome>
    <measure>left and right chamber remodelling and parameters (volume)</measure>
    <time_frame>baseline, 30 days and 12 months</time_frame>
    <description>End-systolic volume End-diastolic volume Left atrial volume</description>
  </other_outcome>
  <other_outcome>
    <measure>left ventricular ejection fraction modification</measure>
    <time_frame>baseline, 30 days and 12 months</time_frame>
    <description>Left ventricular ejection fraction</description>
  </other_outcome>
  <other_outcome>
    <measure>mitral valve remodelling</measure>
    <time_frame>baseline, 30 days and 12 months</time_frame>
    <description>Mitral valve area and mean gradient</description>
  </other_outcome>
  <other_outcome>
    <measure>Left atrial and pulmonary artery pressures</measure>
    <time_frame>baseline, 30 days and 12 months</time_frame>
    <description>Left atrial and pulmonary artery pressures</description>
  </other_outcome>
  <other_outcome>
    <measure>change in 6-minute Walking Test (functional evaluation)</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>6-minute Walking Test</description>
  </other_outcome>
  <other_outcome>
    <measure>surveillance of cardiac and renal function</measure>
    <time_frame>baseline, 30 days, 6, 12 and 24 months</time_frame>
    <description>NT ProBNP or BNP creatininemia, ureamia</description>
  </other_outcome>
  <other_outcome>
    <measure>change in Quality of Life scores</measure>
    <time_frame>baseline, 30 days, 6, 12 and 24 months</time_frame>
    <description>Quality of Life EQ-5D score SF-36 score</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness analysis (economic efficiency)</measure>
    <time_frame>24 months</time_frame>
    <description>Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cardiac surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mitral valve repair in first intervention, valve replacement if repair not feasible</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW</intervention_name>
    <description>percutaneous mitral valve repair Percutaneous MitraClip Device Implantation</description>
    <arm_group_label>MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device</arm_group_label>
    <other_name>MITRACLIP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac surgery</intervention_name>
    <description>mitral valve repair or mitral valve remplacement</description>
    <arm_group_label>cardiac surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Primary Mitral Regurgitation grade 3+ or 4+&#xD;
&#xD;
          -  Patients in class II to IV NYHA&#xD;
&#xD;
          -  Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery&#xD;
&#xD;
          -  Adult patients judged eligible for mitral valve surgery by the local heart team but at&#xD;
             high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index&#xD;
             or one major organ system compromise or one possible procedure-specific impediment&#xD;
             (using MVARC definitions) ; or age &lt; 75 years and STS score &gt; 8 % or at least one&#xD;
             other high-risk criterion following the MVARC definitions; or age &gt; 80 years and&#xD;
             judged at high risk for surgery by the local heart team&#xD;
&#xD;
          -  Isolated Mitral valve pathology&#xD;
&#xD;
          -  If revascularization procedures are required, they must be performed more than 30 days&#xD;
             from intervention (D0)&#xD;
&#xD;
          -  Patients affiliate to social security&#xD;
&#xD;
        Non-inclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt; 1 year due to non-cardiac conditions&#xD;
&#xD;
          -  Secondary Mitral regurgitation&#xD;
&#xD;
          -  Evolving endocarditis or active endocarditis or inflammatory disease in the last 3&#xD;
             months&#xD;
&#xD;
          -  Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet&#xD;
             regimen&#xD;
&#xD;
          -  Rheumatic mitral valve disease&#xD;
&#xD;
          -  Evidence of intracardiac, inferior vena cava or femoral venous thrombus&#xD;
&#xD;
          -  Valve anatomy not compatible with MitraClip® implantation (cf. colum 3 table 3 page&#xD;
             57)&#xD;
&#xD;
          -  Stroke or transient ischaemic event within 30 days before D0&#xD;
&#xD;
          -  Modified Rankin Scale ≥4 disability (appendix 9)&#xD;
&#xD;
          -  TAVR within 30 days before D0-Untreated, clinically significant coronary artery&#xD;
             disease requiring revascularization&#xD;
&#xD;
          -  Any percutaneous cardiovascular intervention within 30 days before D0 including ATC&#xD;
&#xD;
          -  Cardiovascular surgery, or carotid surgery within 30 days before D0&#xD;
&#xD;
          -  Any prior mitral valve surgery or transcatheter mitral valve procedure&#xD;
&#xD;
          -  Need for any concomitant cardiac surgery including treatment of severe secondary&#xD;
             tricuspid regurgitation in accordance with class I recommendation in 2017 ESC&#xD;
             guidelines. Surgical treatment of mild or moderate secondary tricuspid regurgitation&#xD;
             (Class IIa and IIb recommendations) can still be performed in the protocol according&#xD;
             to the local heart team decison&#xD;
&#xD;
          -  NYHA functional class I&#xD;
&#xD;
          -  LVEF &lt; 30%&#xD;
&#xD;
          -  Primary MR grade 1 to 2&#xD;
&#xD;
          -  Subjects in whom transesophageal echocardiography or transseptal catheterization are&#xD;
             contraindicated or high-risk&#xD;
&#xD;
          -  Any condition preventing the patient from completing all protocol procedures&#xD;
             (including compliance with guidelines directed medical therapy) and follow-up visits&#xD;
&#xD;
          -  Patient unable or unwilling to provide written, informed consent before study&#xD;
             enrolment&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship&#xD;
&#xD;
          -  Participation in another trial that would interfere with this trial&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Not eligible for a MitraClip® intervention after Core Lab evaluation&#xD;
&#xD;
          -  Before randomization (D-21) the patient no longer fulfills eligibility criteria&#xD;
             (inclusion criteria and non-inclusion criteria)&#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_contact>
    <last_name>PATRICE GUERIN, MD-PHD</last_name>
    <phone>02.40.16.55.92</phone>
    <email>patrice.guerin@chu-nantes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FREDERIC PINAUD, MD</last_name>
    </contact>
    <investigator>
      <last_name>FREDERIC ROULEAU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>FREDERIC PINAUD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Annecy</name>
      <address>
        <city>Annecy</city>
        <zip>74370</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lionel MANGIN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Augustin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Chu Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LIONEL LEROUX, MD-PHD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chru Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MARTINE GILARD, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor Aphp</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>EMMANUEL TEIGER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>OLIVIER CHAVANON, MD-PHD</last_name>
    </contact>
    <investigator>
      <last_name>OLIVIER CHAVANON, MD-PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>CAROLE SAUNIER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Chirurgical Marie Lannelongue</name>
      <address>
        <city>Le Plessis-Robinson</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SAID GHOSTINE, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chru Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ERIC VAN BELLE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Prive Le Bois Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine JEU</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique de La Sauvegarde</name>
      <address>
        <city>Lyon</city>
        <zip>69009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FRANCK SIBELLAS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU LYON</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JEAN-FRANCOIS OBADIA, MD-PHD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Prive Clairval</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hopital La Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital St Joseph</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>THIERRY LEFEVRE, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Du Millenaire</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CATHERINE SPORTOUCH-DUKHAN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PATRICE GUERIN, MD-PHD</last_name>
    </contact>
    <investigator>
      <last_name>THOMAS SENAGE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>NICOLAS PIRIOU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Bichat</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DOMINIQUE HIMBERT, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NICOLE KARAM, MD-PHD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital La Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JEAN-PHILIPPE COLLET</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHRISTELLE DIAKOV</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Chu Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GUILLAUME LEURENT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Centre Cardiologique Du Nord</name>
      <address>
        <city>Saint-Denis</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MOHAMMED NEJJARI</last_name>
    </contact>
    <investigator>
      <last_name>MOHAMMED NEJJARI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>DAVID ATTIAS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Saint Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42277</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JEAN-PIERRE FAVRE, MD-PHD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Civil Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PATRICK OHLMANN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DIDIER TCHETCHE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>THIBAULT LHERMUSIER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chru Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHRISTOPHE SAINT ETIENNE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Du Tonkin</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DIDIER CHAMPAGNAC</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Cardio-Thoracique de Monaco</name>
      <address>
        <city>Monaco</city>
        <country>Monaco</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>France</country>
    <country>Monaco</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MITRACLIP</keyword>
  <keyword>primary Mitral Regurgitation</keyword>
  <keyword>high surgical risks</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</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/NCT03271762
org study id: RC17_0002
nct id: NCT03271762
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an
      endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment
      strategy in patients with severe primary mitral regurgitation judged eligible for anatomical
      repair with the MitraClip® or mitral valve surgery with high surgical risk.

      This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled
      will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12
      months, phone call at 18 months and clincial visit at 24 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention
time frame: 12 months
description: comparison between arms of:
number and reason of death
number and reason unplanned rehospitalisation for cardiovascular reasons,
number of mitral valve reintervention
measure: occurrence of a major adverse event
time frame: 30 days
description: all-cause death, need for non-elective cardiovascular or thoracic surgery, device or procedure-related adverse events, major bleeding complications or serious bleeding, major access site vascular complications, major cardiac structural complications, pulmonary complications (device or procedure-related), stroke and other cerebrovascular events, myocardial infarction, acute kidney injury or progression of chronic kidney disease, arrhythmias and conduction system disturbances, unplanned mitral valve surgery due to device/procedure failure or malfunction, requirement for valve replacement after valve repair failure, unplanned cardiac surgery for any cause
measure: Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs)
time frame: 6, 12 and 24 months
description: SAEs et SADEs rate related to protocol procedure all SAEs and SADEs
measure: all-cause mortality
time frame: 30 days and 6, 12 and 24 months
description: Rate of global mortality (all-causes)
measure: cardiovascular mortality
time frame: 30 days and 6, 12 and 24 months
description: Rate of cardiovascular mortality
measure: unplanned heart failure rehospitalization
time frame: 6, 12 and 24 months
description: Rate of unplanned heart failure rehospitalization
measure: unplanned rehospitalization rate for cardiovascular reasons
time frame: 30 days 6, 12 and 24 months
description: Rate of unplanned rehospitalization for cardiovascular reasons
measure: mitral valve reintervention
time frame: 30 days 6, 12 and 24 months
description: Mitral valve reintervention rate
measure: residual MR
time frame: 30 days 6, 12 and 24 months
description: MR (Mitral Regurgitation): grade
measure: left and right chamber remodelling and parameters (dimension)
time frame: baseline, 30 days and 12 months
description: End-systolic dimension End-diastolic dimension Left atrial dimension
measure: left and right chamber remodelling and parameters (volume)
time frame: baseline, 30 days and 12 months
description: End-systolic volume End-diastolic volume Left atrial volume
measure: left ventricular ejection fraction modification
time frame: baseline, 30 days and 12 months
description: Left ventricular ejection fraction
measure: mitral valve remodelling
time frame: baseline, 30 days and 12 months
description: Mitral valve area and mean gradient
measure: Left atrial and pulmonary artery pressures
time frame: baseline, 30 days and 12 months
description: Left atrial and pulmonary artery pressures
measure: change in 6-minute Walking Test (functional evaluation)
time frame: baseline, 6 and 12 months
description: 6-minute Walking Test
measure: surveillance of cardiac and renal function
time frame: baseline, 30 days, 6, 12 and 24 months
description: NT ProBNP or BNP creatininemia, ureamia
measure: change in Quality of Life scores
time frame: baseline, 30 days, 6, 12 and 24 months
description: Quality of Life EQ-5D score SF-36 score
measure: Cost-effectiveness analysis (economic efficiency)
time frame: 24 months
description: Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)
arm group label: MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device
arm group type: Experimental
description: MitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
arm group label: cardiac surgery
arm group type: Active Comparator
description: mitral valve repair in first intervention, valve replacement if repair not feasible
intervention type: Device
intervention name: percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
description: percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
arm group label: MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device
other name: MITRACLIP
intervention type: Procedure
intervention name: cardiac surgery
description: mitral valve repair or mitral valve remplacement
arm group label: cardiac surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: PATRICE GUERIN, MD-PHD
phone: 02.40.16.55.92
email: patrice.guerin@chu-nantes.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
country: France
country: Monaco
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency