RecruitingNot ApplicableNCT07501234

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

Sponsor

Mitrassist Lifesciences Limited Co., Ltd.

Enrollment

5 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Mitral Regurgitation (MR)

Summary

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. The main questions it aims to answer are: Is 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? Participants will: Receive the MitraFix valve through a small tube inserted into a vein in the leg. Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Moderate to severe or severe (≥3+) mitral regurgitation.
Age ≥ 18 years.
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.
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.
Able to understand the study purpose, voluntarily participate, sign the informed consent form, and willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria24

Severe mitral stenosis.
Severe calcification of mitral leaflets and/or annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation.
High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT/TEE planning (estimated neo-LVOT \< 150 mm²), which cannot be avoided by procedural optimization.
Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.).
Infective endocarditis or evidence of active infection.
Stroke or transient ischemic attack (TIA) within 90 days.
Severe untreated coronary artery disease or acute myocardial infarction within 90 days; or percutaneous coronary intervention (PCI)/coronary stent implantation within 90 days.
Severe pulmonary hypertension (resting PASP \> 70 mmHg, assessed as irreversible).
Severe right ventricular dysfunction: Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 17 mm.
Concomitant tricuspid valve, aortic valve, or severe great vessel disease requiring surgical or interventional treatment.
Left ventricular ejection fraction (LVEF) \< 30%.
Extreme frailty preventing tolerance of the procedure, or in a state of shock requiring circulatory support.
Implantation of CRT, CRT-D, or implantable cardioverter-defibrillator (ICD) within 30 days.
Chronic dialysis or expected need for long-term dialysis; or severe renal impairment (e.g., eGFR \< 30 mL/min/1.73m²) unable to undergo perioperative dialysis.
Documented coagulopathy or severe hematological disorders (e.g., platelet count \< 50×10\^9/L, active bleeding), or history of heparin-induced thrombocytopenia (HIT).
Contraindications to anticoagulant/antiplatelet therapy that cannot be substituted or bridged.
Echocardiographic evidence of any intracardiac mass, or thrombus in the left ventricle or left atrium (including left atrial appendage).
Contraindications to transesophageal echocardiography (TEE).
Severe allergy to iodine contrast media, nitinol, bovine-derived materials, or other device materials that remains intolerable despite premedication.
Life expectancy \< 12 months.
Pregnant or breastfeeding women.
Unsuitable for the transfemoral-transseptal approach (e.g., femoral vein diameter, calcification, tortuosity, or atrial septum/left atrial anatomy not meeting delivery system requirements).
Participation in another clinical study of an investigational device or drug within 3 months prior to screening that may interfere with this study.
Any other conditions deemed unsuitable for enrollment by the investigator.