[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mitrassist Lifesciences Limited Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":20,"type":21},5,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Mitral Regurgitation (MR)",[29,30],"MitraFix","Transcatheter Mitral Valve Replacement","RECRUITING","2026-03-26",{"date":34,"type":35},"2026-03-30","ACTUAL",{"date":37,"type":21},"2026-03-23",{"date":39,"type":21},"2028-10-23",{"name":41,"class":42},"Mitrassist Lifesciences Limited Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"100600457","early-feasibility-study-of-surgical-implantation-of-a-polymer-prosthetic-mitral-and-aortic-valve-100600457","NCT07097740","Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve","A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve","POLYVALVE-FIH","Inclusion Criteria:\n\n* Adults requiring surgical replacement of either mitral or aortic valve\n* Capable of undergoing cardiopulmonary bypass\n* Able to tolerate anticoagulation therapy\n* Able to understand study purpose, willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty \\[PBMV\\], which is permitted).\n2. Requirement for urgent or emergency cardiac surgery.\n3. Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).\n4. Scheduled coronary artery bypass graft (CABG) during the same admission.\n5. Anticipated need for additional non-valve cardiac surgery within 12 months.\n6. Active systemic infection, including pneumonia or infective endocarditis.\n7. Intracardiac thrombus detected on echocardiography or imaging.\n8. Stroke or transient ischemic attack within the prior 3 months.\n9. Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.\n10. Severe comorbidities with expected life expectancy \\\u003C12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.\n11. Participation in another interventional clinical trial involving investigational devices or drugs.\n12. Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.\n13. Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.\n14. Severe renal insufficiency, e.g., estimated GFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for chronic dialysis.\n15. Coagulopathy or active bleeding disorders, e.g., INR \\>1.5 without anticoagulation therapy.\n16. Hematologic abnormalities: hematocrit \\\u003C30%, hemoglobin \\\u003C100 g\u002FL, platelet count \\\u003C100 × 10⁹\u002FL, or WBC \\\u003C4 × 10⁹\u002FL or \\>10 × 10⁹\u002FL.\n17. History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.\n18. Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.\n19. Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.\n20. Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).","50 Years",{"count":54,"type":21},10,[24],"The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.\n\nThe main question it aims to answer is:\n\n\\-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?\n\nParticipants will undergo:\n\n* Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).\n* Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.",[58,59,60,61,62,63],"AORTIC VALVE DISEASES","Mitral Valve Disease","Aortic Stenosis","Aortic Regurgitation","Mitral Stenosis","Mitral Regurgitation","2025-07-24",{"date":66,"type":35},"2025-07-31",{"date":68,"type":35},"2025-06-27",{"date":70,"type":21},"2027-06",{"name":41,"class":42},""]