[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100280084":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":23,"locations":29,"responsibleParty":67,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":82,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"French Cardiology Society","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"SEVERE MITRAL VALVE DISEASE",null,"All patients with symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement, and not eligible for surgery according to the heart-team.",[13,17,20],{"name":14,"affiliation":15,"role":16},"Jean-François OBADIA","Hospices Civils de Lyon","PRINCIPAL_INVESTIGATOR",{"name":18,"affiliation":19,"role":16},"Bernard IUNG","Assistance Publique - Hôpitaux de Paris",{"name":21,"affiliation":22,"role":16},"Patrice GUERIN","Nantes University Hospital",[24,28],{"name":14,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","+331 43 22 33 33","secretariat.registre@sfcardio.fr",{"name":18,"role":25,"phone":26,"phoneExt":10,"email":27},[30,45,56],{"facility":31,"status":32,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"CHU Lyon","RECRUITING","Lyon","France","FR",{"type":37,"coordinates":38},"Point",[39,40],4.84789,45.74906,{"lat":40,"lon":39},[43],{"name":44,"role":25,"phone":10,"phoneExt":10,"email":10},"Jean-Francois Obadia",{"facility":46,"status":32,"city":47,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"CHU Nantes","Nantes",{"type":37,"coordinates":49},[50,51],-1.55336,47.21725,{"lat":51,"lon":50},[54],{"name":55,"role":25,"phone":10,"phoneExt":10,"email":10},"Patrice Guérin",{"facility":57,"status":32,"city":58,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Bichat Hospital","Paris",{"type":37,"coordinates":60},[61,62],2.3488,48.85341,{"lat":62,"lon":61},[65],{"name":66,"role":25,"phone":10,"phoneExt":10,"email":10},"Bernard Iung",{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100280084","management-and-clinical-outcomes-of-patients-with-severe-mitral-valve-disease-not-suitable-for-surgery-100280084",false,"NCT02925819","Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery","Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study","MITRAGISTER","* Aged over 18 years\n* Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)\n* Symptomatic (NYHA functional class II-IV) despite optimized medical therapy\n* Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called \"heart team\" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.\n* Having received information about the study and not expressing opposition to the use of their data\n* Patient not included in a clinical trial\n\nExclusion Criteria:\n\n* Asymptomatic patients\n* Absence of severe mitral regurgitation or stenosis\n* Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called \"heart team\" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.\n* Pregnant or breastfeeding women\n* Having not received information about the study or having expressed opposition to the use of their data","ALL","18 Years",{"count":80,"type":81},500,"ESTIMATED","2 Years","OBSERVATIONAL","The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.",[86],"Mitral Valve Disease",[88,89,90,91],"Mitral regurgitation","Mitral stenosis","Mitral valve repair deterioration","Bioprosthesis degeneration","2026-06-11",{"date":94,"type":95},"2026-06-12","ACTUAL",{"date":97,"type":95},"2016-10",{"date":99,"type":81},"2026-12",{"name":5,"class":6},3]