Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System (MITRA-EFS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation (MR)
• Intervention / Treatment: Device: MitraFix® Transcatheter Mitral Valve System

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: NaXin Di; Phone Number: 021-69925338; Email: tina.ti@mitrassist.com.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Wang ShouZheng; Phone Number: +86-18721127040; Email: DrWang0229@163.com
      • Principal Investigator: Wang Shouzheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MitraFix System; 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; The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success Rate	Percentage of participants achieving technical success, defined as successful access, delivery, and deployment of the device, and successful retrieval of the delivery system.	Intra-operative (At the time of procedure)
Procedural Success Rate	Percentage of participants achieving procedural success, typically defined as technical success without the occurrence of major device- or procedure-related serious adverse events.	30 days post-procedure
Valve Performance Assessment	Evaluated by echocardiography, including the severity of residual mitral regurgitation, transvalvular pressure gradient, and the presence/severity of paravalvular leak.	Up to 12 months post-procedure
Change in New York Heart Association (NYHA) Functional Class	Assessment of clinical improvement in heart failure symptoms based on the NYHA classification (Class I to IV, where a lower class indicates better function).	Up to 12 months post-procedure
Change in Quality of Life Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Quality of life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ Overall Summary Score ranges from 0 to 100. Higher scores indicate fewer symptoms and better health-related quality of life.	Up to 12 months post-procedure
Change in 6-Minute Walk Distance	The change in the total distance (in meters) a participant can walk on a flat surface in 6 minutes, used to evaluate exercise capacity.	Up to 12 months post-procedure
Rate of Hospitalization for Heart Failure	Number of participants requiring hospital admission or an emergency/urgent care visit for the treatment of worsening heart failure.	Up to 12 months post-procedure
Incidence of Major Adverse Events (MAEs)	Number of participants experiencing major adverse events, such as all-cause mortality, stroke, life-threatening bleeding, or acute kidney injury.	Up to 12 months post-procedure
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants experiencing any device-related or procedure-related adverse events and serious adverse events.	Up to 12 months post-procedure

Collaborators and Investigators

• Sponsor: Mitrassist Lifesciences Limited Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): March 23, 2028
• Study Completion (Estimated): October 23, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Transcatheter Mitral Valve Replacement; MitraFix
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: TF-TMVR-EFS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No