[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648683":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":56,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":17,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":20,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transventricular off-pump mitral valve repair","EXPERIMENTAL","Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.",[13],"Device: TRANSOM",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","TRANSOM","TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"James Gammie, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Lisa Fornaresio, PhD","CONTACT","443.927.3984","lisa.fornaresio@jhmi.edu",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Rachael Quinn, PhD","410.955.2800","rquinn17@jhmi.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Johns Hopkins Hospital","RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-76.61219,39.29038,{"lat":48,"lon":47},[51,53,54],{"name":27,"role":28,"phone":52,"phoneExt":20,"email":30},"443-927-3984",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"name":55,"role":24,"phone":20,"phoneExt":20,"email":20},"James S. Gammie, MD",{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100648683","transventricular-off-pump-mitral-valve-repair-100648683",false,"NCT07726173","Transventricular Off-pump Mitral Valve Repair","Transventricular Off-pump Mitral Valve Repair (TRANSOM)","Inclusion Criteria:\n\n* Age 21 years or older.\n* Presence of severe degenerative mitral regurgitation confirmed by echocardiography.\n* Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.\n* Ability to provide informed consent and willingness to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Functional mitral regurgitation.\n* Severe mitral annular or leaflet calcification.\n* Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).\n* Left ventricular ejection fraction \\\u003C30% or severe right ventricular dysfunction.\n* Requirement for concomitant cardiac surgery.\n* Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).\n* Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).\n* Hemodynamic instability or cardiogenic shock at the time of enrollment.\n* Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.\n* Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.\n* Pregnancy, lactation, or planned pregnancy during the study period.\n* Participation in another investigational device or drug study that could interfere with outcomes.\n* Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.","ALL","21 Years",{"count":68,"type":69},175,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.",[75],"Mitral Valve (MV) Regurgitation","2026-07-20",{"date":78,"type":79},"2026-07-24","ACTUAL",{"date":81,"type":79},"2026-06-08",{"date":83,"type":69},"2029-07-01",{"name":5,"class":6},1]