[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639768":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":50,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":19,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"ReValve Solutions Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm Study","EXPERIMENTAL","Device: ReValve System",[11],[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","ReValve System","Mitral Valve Replacement Device",[9],null,[21,40],{"facility":22,"status":23,"city":24,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Institute Dante Pazzanese of Cardiology - IDPC","RECRUITING","São Paulo","SP, 04012-909","Brazil","BR",{"type":29,"coordinates":30},"Point",[31,32],-46.63611,-23.5475,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},"Study Coordinator","CONTACT","+55 11 5085-6000","diretoriageral@dantepazzanese.org.br",{"facility":41,"status":23,"city":24,"state":24,"zip":42,"country":26,"countryCode":27,"cosmosGeoPoint":43,"geoPoint":45,"contacts":46},"The Heart Institute - INCOR","SP, 05403-900",{"type":29,"coordinates":44},[31,32],{"lat":32,"lon":31},[47],{"name":36,"role":37,"phone":48,"phoneExt":19,"email":49},"+55 11 2661-5000","larissa.katipian@hc.fm.usp.br",{"type":51,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100639768","early-phase-1-replacement-of-the-native-mitral-valve-using-the-revalve-system-100639768",false,"NCT07601269","Replacement of the Native Mitral Valve Using the ReValve System","A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System","Key Inclusion Criteria:\n\n* Symptomatic functional and\u002For degenerative MR (≥2+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.\n* Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac CT.\n* Age greater than 18 years.\n* Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.\n\nKey Exclusion Criteria:\n\n* Untreated clinically significant coronary artery disease requiring revascularization.\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n* Status 1 heart transplant or prior orthotopic heart transplantation.\n* Cerebrovascular accident within 30 days prior to subject's consent.\n* Pregnant or planning pregnancy within next 12 months.\n* Currently participating in an investigational drug or another device study.\n* Evidence of LV or LA thrombus, vegetation or mass\n* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.","ALL","18 Years",{"count":62,"type":63},25,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","This study is to collect preliminary chronic information on performance and safety of the ReValve System.",[69],"Mitral Valve Replacement","2026-05-16",{"date":72,"type":73},"2026-05-22","ACTUAL",{"date":75,"type":73},"2026-04-26",{"date":77,"type":63},"2028-04",{"name":5,"class":6},2]