[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631480":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Mitrassist Lifesciences Limited Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MitraFix System","EXPERIMENTAL","Participants with moderate-to-severe or severe (≥3+) mitral regurgitation who are at high surgical risk will receive the MitraFix® Transcatheter Mitral Valve System.",[13],"Device: MitraFix® Transcatheter Mitral Valve System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MitraFix® Transcatheter Mitral Valve System","The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"NaXin Di","CONTACT","021-69925338","tina.ti@mitrassist.com.cn",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Fuwai Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100037","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},[43,47],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Wang ShouZheng","+86-18721127040","DrWang0229@163.com",{"name":48,"role":49,"phone":20,"phoneExt":20,"email":20},"Wang Shouzheng","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100631480","safety-and-feasibility-study-of-the-mitrafix-transcatheter-mitral-valve-system-100631480",false,"NCT07501234","Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System","A Prospective Clinical Study to Evaluate the Safety and Clinical Feasibility of the MitraFix® Transcatheter Mitral Valve System","MITRA-EFS","Inclusion Criteria:\n\n* Moderate to severe or severe (≥3+) mitral regurgitation.\n* Age ≥ 18 years.\n* Patients at high risk for traditional open-heart surgery, defined as: STS mortality risk for mitral valve replacement ≥ 8%; OR presence of 2 or more frailty indices; OR presence of 2 or more major organ dysfunctions that cannot be improved post-operatively; OR other comorbidities or factors making them unsuitable for surgery.\n* Anatomically suitable for transcatheter MitraFix® system implantation via a transfemoral-transseptal approach as assessed by the investigator; the transfemoral-transseptal access route meets the requirements of the delivery system.\n* Able to understand the study purpose, voluntarily participate, sign the informed consent form, and willing to accept relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n* Severe mitral stenosis.\n* Severe calcification of mitral leaflets and\u002For annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation.\n* High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT\u002FTEE planning (estimated neo-LVOT \\\u003C 150 mm²), which cannot be avoided by procedural optimization.\n* Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.).\n* Infective endocarditis or evidence of active infection.\n* Stroke or transient ischemic attack (TIA) within 90 days.\n* Severe untreated coronary artery disease or acute myocardial infarction within 90 days; or percutaneous coronary intervention (PCI)\u002Fcoronary stent implantation within 90 days.\n* Severe pulmonary hypertension (resting PASP \\> 70 mmHg, assessed as irreversible).\n* Severe right ventricular dysfunction: Tricuspid Annular Plane Systolic Excursion (TAPSE) \\\u003C 17 mm.\n* Concomitant tricuspid valve, aortic valve, or severe great vessel disease requiring surgical or interventional treatment.\n* Left ventricular ejection fraction (LVEF) \\\u003C 30%.\n* Extreme frailty preventing tolerance of the procedure, or in a state of shock requiring circulatory support.\n* Implantation of CRT, CRT-D, or implantable cardioverter-defibrillator (ICD) within 30 days.\n* Chronic dialysis or expected need for long-term dialysis; or severe renal impairment (e.g., eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²) unable to undergo perioperative dialysis.\n* Documented coagulopathy or severe hematological disorders (e.g., platelet count \\\u003C 50×10\\^9\u002FL, active bleeding), or history of heparin-induced thrombocytopenia (HIT).\n* Contraindications to anticoagulant\u002Fantiplatelet therapy that cannot be substituted or bridged.\n* Echocardiographic evidence of any intracardiac mass, or thrombus in the left ventricle or left atrium (including left atrial appendage).\n* Contraindications to transesophageal echocardiography (TEE).\n* Severe allergy to iodine contrast media, nitinol, bovine-derived materials, or other device materials that remains intolerable despite premedication.\n* Life expectancy \\\u003C 12 months.\n* Pregnant or breastfeeding women.\n* Unsuitable for the transfemoral-transseptal approach (e.g., femoral vein diameter, calcification, tortuosity, or atrial septum\u002Fleft atrial anatomy not meeting delivery system requirements).\n* Participation in another clinical study of an investigational device or drug within 3 months prior to screening that may interfere with this study.\n* Any other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":63,"type":64},5,"ESTIMATED","INTERVENTIONAL",[67],"NA","The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery.\n\nThe main questions it aims to answer are:\n\nIs the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life?\n\nParticipants will:\n\nReceive the MitraFix valve through a small tube inserted into a vein in the leg.\n\nVisit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.",[70],"Mitral Regurgitation (MR)",[72,73],"MitraFix","Transcatheter Mitral Valve Replacement","2026-03-26",{"date":76,"type":77},"2026-03-30","ACTUAL",{"date":79,"type":64},"2026-03-23",{"date":81,"type":64},"2028-10-23",{"name":5,"class":6},1]