[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Capstan Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100562209","capstan-medical-tmvr-study-fih-100562209",false,"NCT06600191","Capstan Medical TMVR Study: FIH","Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of consent.\n* Moderate-severe (3+) or severe (4+) mitral regurgitation\n* NYHA II or greater symptoms despite optimal medical treatment.\n* The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).\n* Ability and willingness to provide written informed consent prior to any study related procedure(s).\n\nExclusion Criteria:\n\n* LVEF less than 20%\n* Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System\n* Severe aortic valve stenosis or regurgitation\n* Severe mitral stenosis\n* Severe right ventricular dysfunction or severe tricuspid valve disease\n* Evidence of intracardiac thrombus, vegetation, or mass\n* Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve\n* Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure\n* Myocardial infarction within 30 days prior to procedure\n* Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure\n* Active endocarditis, other ongoing infection requiring antibiotic therapy\n* Stroke or transient ischemic attack (TIA) within 30 days of procedure\n* Active peptic ulcer or active gastrointestinal bleeding\n* Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg\n* End-stage renal failure on dialysis\n* Life expectancy less than 1 year\n* Subject is on the waiting list for a heart transplant or has had a prior heart transplant\n* Pregnant (Participants of childbearing age are required to have a negative pregnancy test).\n* Known allergy to antiplatelet therapy, heparin, or to device materials\n* Inability to tolerate anticoagulation or antiplatelet therapies\n* Absence of appropriate venous access\n* Unable to have transesophageal echocardiography\n* Unwillingness to complete the required follow-up visits","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.",[26],"Mitral Regurgitation",[28,29],"TMVR","mitral regurgitation","RECRUITING","2026-07-14",{"date":33,"type":34},"2026-07-15","ACTUAL",{"date":36,"type":34},"2025-02-24",{"date":38,"type":20},"2031-12",{"name":40,"class":41},"Capstan Medical","INDUSTRY",3,""]