[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100364753":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":174,"collaborators":19,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":19,"eligibilityCriteria":181,"healthyVolunteers":178,"sex":182,"minAge":183,"maxAge":19,"enrollmentInfo":184,"targetDuration":19,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"HighLife SAS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcatheter Mitral Valve Replacement","EXPERIMENTAL","HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools.",[13],"Device: Transcatheter Mitral Valve Replacement",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system",[9],null,[21,41,58,74,89,105,121,132,148,164],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Tucson Medical Center","RECRUITING","Tucson","Arizona","85712","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-110.92648,32.22174,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Thomas Waggoner, MD","CONTACT","+1 520-838-3540","Thomas Waggoner 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863-3900","paul.sorajja@allina.com",{"name":101,"role":57,"phone":19,"phoneExt":19,"email":19},{"facility":106,"status":23,"city":107,"state":107,"zip":108,"country":27,"countryCode":28,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Montefiore Medical Center","New York","10467",{"type":30,"coordinates":110},[111,112],-74.00597,40.71427,{"lat":112,"lon":111},[115,119],{"name":116,"role":38,"phone":117,"phoneExt":19,"email":118},"Azeem Latib, MD","(718) 920-4321","mlatib@montefiore.org",{"name":120,"role":57,"phone":19,"phoneExt":19,"email":19},"Azim Latib, MD",{"facility":122,"status":123,"city":124,"state":125,"zip":126,"country":27,"countryCode":28,"cosmosGeoPoint":127,"geoPoint":131,"contacts":19},"University of 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MD","(713) 790-3311","ssgoel@houstonmethodist.org",{"name":160,"role":57,"phone":19,"phoneExt":19,"email":19},{"facility":165,"status":123,"city":166,"state":167,"zip":168,"country":27,"countryCode":28,"cosmosGeoPoint":169,"geoPoint":173,"contacts":19},"Chippenham Hospital Richmond","Richmond","Virginia","23225",{"type":30,"coordinates":170},[171,172],-77.46026,37.55376,{"lat":172,"lon":171},{"type":175,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100364753","an-early-feasibility-study-of-the-highlife-28mm-trans-septal-transcatheter-mitral-valve-replacement-system-100364753",false,"NCT04029337","An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Severe mitral regurgitation\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.\n* Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months\n* Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair\u002Freplacement due to significant co-morbid conditions\n* Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions\n* Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE\n\nMain Exclusion Criteria:\n\n* Mitral stenosis\n* Rheumatic valve disease\n* Severe calcifications of the mitral annulus and\u002For mitral leaflets\n* Prior surgical or interventional treatment of the mitral valve\n* Unsuitable anatomy for the transapical access\n* Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access\n* Untreated clinically significant coronary artery disease requiring revascularization\n* LVEF \\\u003C 30%\n* LVEDD \\> 70mm\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* Hypertrophic Obstructive Cardiomyopathy (HOCM)\n* Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure","ALL","18 Years",{"count":185,"type":186},30,"ESTIMATED","INTERVENTIONAL",[189],"NA","Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.",[192],"Mitral Regurgitation","2025-03-12",{"date":195,"type":196},"2025-03-17","ACTUAL",{"date":198,"type":196},"2020-07-14",{"date":200,"type":186},"2030-12",{"name":5,"class":6},10]