[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607413":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"HVR Cardio Oy","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","OTHER",null,[13],"Device: Transcatheter Mitral Valve Repair",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Transcatheter Mitral Valve Repair","Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation",[9],[21],{"name":22,"affiliation":23,"role":24},"Vinayak Bapat","Abbott Northwestern and United Hospitals","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Thomas Fleming","CONTACT","612 940 8037","tom@hvrcardio.com",[32,47],{"facility":33,"status":34,"city":35,"state":36,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Tbilisi Heart and Vascular Clinic","RECRUITING","Tbilisi","Georgia","GE",{"type":39,"coordinates":40},"Point",[41,42],44.83412,41.69143,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":11,"phoneExt":11,"email":11},"Tamaz Shaburishvili",{"facility":48,"status":34,"city":49,"state":50,"zip":11,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Vilnius University Hospital, Santaros Klinikos, Public Institution","Vilnius","Lithuania","LT",{"type":39,"coordinates":53},[54,55],25.2798,54.68916,{"lat":55,"lon":54},[58],{"name":59,"role":24,"phone":11,"phoneExt":11,"email":11},"Giedrius Davidavičius",{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607413","mitral-annular-repair-with-the-cathhelix-transcatheter-system-in-subjects-with-fmr-100607413",false,"NCT07188233","Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR","A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation","MARCH","Inclusion Criteria:\n\n* Moderate to severe (3+) or severe (4+) functional mitral regurgitation\n* Left ventricular ejection fraction ≥30%\n* Symptomatic New York Heart Association (NYHA) Class II to IV).\n\nExclusion Criteria:\n\n* Oxygen dependent for COPD\n* Active or suspected endocarditis\n* Severe symptomatic carotid stenosis\n* Has undergone heart transplantation.\n* Severe calcification of the mitral annulus or leaflets\n* Coronary sinus anatomy that may preclude proper treatment with the device","ALL","18 Years",{"count":73,"type":74},5,"ESTIMATED","INTERVENTIONAL",[77],"NA","Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.",[80],"Mitral Valve Regurgitation (Degenerative or Functional)","2025-09-20",{"date":83,"type":84},"2025-09-23","ACTUAL",{"date":86,"type":84},"2024-11-16",{"date":88,"type":74},"2026-07",{"name":5,"class":6},2]