Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System

NCT07501234 | Recruiting

• 1 other identifier: TF-TMVR-EFS-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation (MR)

Keywords

MitraFix; Transcatheter Mitral Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Device Success Rate

  evice success is defined as the patient being alive and free from stroke, with the implanted valve in the intended position and functioning properly, without the need for re-operation or re-intervention due to device-related complications.

  30 days post-procedure

Secondary Outcomes (9)

• Technical Success Rate

  Intra-operative (At the time of procedure)

• Procedural Success Rate

  30 days post-procedure

• Valve Performance Assessment

  Up to 12 months post-procedure

• Change in New York Heart Association (NYHA) Functional Class

  Up to 12 months post-procedure

• Change in Quality of Life Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

  Up to 12 months post-procedure

Study Arms (1)

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.

Device: MitraFix® Transcatheter Mitral Valve System

Interventions

MitraFix® Transcatheter Mitral Valve System DEVICE

The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.

MitraFix System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mitrassist Lifesciences Limited Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

NaXin Di

CONTACT

021-69925338; tina.ti@mitrassist.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 23, 2028
• Study Completion (Estimated): October 23, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)