[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627613":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":57,"collaborators":11,"id":59,"slug":11,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":23,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"ReValve Solutions Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm Study","EXPERIMENTAL",null,[13],"Device: ReValve System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","ReValve System","Mitral Valve Replacement Device",[9],[21,38,48],{"facility":22,"status":23,"city":24,"state":11,"zip":11,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Healthycore","RECRUITING","Tbilisi","Georgia",{"type":27,"coordinates":28},"Point",[29,30],44.83412,41.69143,{"lat":30,"lon":29},[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Site Coordinator","CONTACT","+995 32 243 33 43","info@hcore.ge",{"facility":39,"status":23,"city":24,"state":11,"zip":11,"country":25,"cosmosGeoPoint":40,"geoPoint":42,"contacts":43},"Tbilisi Heart and Vascular Center",{"type":27,"coordinates":41},[29,30],{"lat":30,"lon":29},[44],{"name":45,"role":35,"phone":46,"phoneExt":11,"email":47},"Study Coordinator","+995 32 218 15 55","info@thvc.ge",{"facility":49,"status":23,"city":24,"state":11,"zip":11,"country":25,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"Tiblisi Heart Center",{"type":27,"coordinates":51},[29,30],{"lat":30,"lon":29},[54],{"name":45,"role":35,"phone":55,"phoneExt":11,"email":56},"+995 32 250 81 06","info@tbhc.ge",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100627613",false,"NCT07450911","A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System","Key Inclusion Criteria:\n\n* Symptomatic MR (≥3+) 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 magnetic resonance imaging (MRI)).\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 left atrium (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":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.",[74],"Mitral Regurgitation","2026-03-03",{"date":77,"type":78},"2026-03-05","ACTUAL",{"date":80,"type":78},"2026-01-27",{"date":82,"type":68},"2028-01-01",{"name":5,"class":6},3]