MitraFix transcatheter mitral valve system for high-risk severe mitral regurgitation

A Prospective Clinical Study to Evaluate the Safety and Clinical Feasibility of the MitraFix® Transcatheter Mitral Valve System

This trial will test the MitraFix transcatheter mitral valve system to see if it can be safely implanted and reduce severe leaky mitral valves in adults at high risk for open-heart surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mitrassist Lifesciences Limited Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07501234 on ClinicalTrials.gov

What this trial studies

This is an early feasibility interventional study of the MitraFix® Transcatheter Mitral Valve System in adults with moderate-to-severe or severe mitral regurgitation who are high surgical risk. The device is delivered via a transfemoral-transseptal approach through a small catheter inserted in a leg vein and deployed in the mitral position. Participants will be followed with heart imaging, functional walking tests, and clinical assessments for up to one year to document procedural success, reduction in regurgitation, safety events, and symptom changes. The primary focus is on device safety, implant success, and early clinical and functional outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) with moderate-to-severe or severe (≥3+) mitral regurgitation who are considered high risk for conventional surgery and have anatomy suitable for transfemoral-transseptal MitraFix implantation are ideal candidates.

Not a fit: Patients with severe mitral stenosis, heavy leaflet or annular calcification, unsuitable mitral anatomy for the device, or those who are appropriate candidates for standard surgical repair/replacement are unlikely to benefit.

Why it matters

Potential benefit: If successful, this device could provide a less invasive option to reduce mitral regurgitation and improve symptoms for patients who cannot undergo open-heart surgery.

How similar studies have performed: Early feasibility and compassionate-use experiences with other transcatheter mitral valve systems have shown procedural feasibility in selected patients, but long-term outcomes and broad success remain limited, so the approach is still largely experimental.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Beijing, Beijing Municipality

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: NaXin Di

Conditions Mitral Regurgitation; MitraFix; Transcatheter Mitral Valve Replacement