Actively Recruiting
Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
Led by Mitrassist Lifesciences Limited Co., Ltd. · Updated on 2026-03-30
5
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe or severe (+) mitral regurgitation.
- Age 18 years or older.
- High risk for traditional open-heart surgery, defined by STS mortality risk 8%, or presence of 2 or more frailty indices, or presence of 2 or more major organ dysfunctions that cannot be improved after surgery, or other factors making surgery unsuitable.
- Anatomically suitable for MitraFix4 device implantation via transfemoral-transseptal approach.
- Able to understand study purpose, voluntarily participate, sign informed consent, and accept examinations and follow-ups.
You will not qualify if you...
- Severe mitral stenosis.
- Severe calcification of mitral leaflets or annulus; unsuitable mitral valve anatomy.
- High risk of left ventricular outflow tract obstruction not avoidable by procedure.
- Previous mitral valve implants (bioprosthetic or mechanical valves, annuloplasty rings).
- Active infection or infective endocarditis.
- Stroke or transient ischemic attack within 90 days.
- Severe untreated coronary artery disease, recent heart attack, or recent stent implantation within 90 days.
- Severe pulmonary hypertension with resting PASP > 70 mmHg.
- Severe right ventricular dysfunction (TAPSE < 17 mm).
- Other valve or great vessel disease requiring surgery or intervention.
- Left ventricular ejection fraction below 30%.
- Extreme frailty or shock requiring circulatory support.
- Recent implantation of CRT, CRT-D, or ICD within 30 days.
- Chronic or expected long-term dialysis or severe renal impairment.
- Blood clotting disorders or severe blood diseases.
- Contraindications to anticoagulant or antiplatelet therapy.
- Intracardiac mass or thrombus in left heart chambers.
- Contraindications to transesophageal echocardiography.
- Severe allergies to device materials or contrast media.
- Life expectancy under 12 months.
- Pregnant or breastfeeding women.
- Unsuitable anatomy for transfemoral-transseptal approach.
- Recent participation in other investigational device or drug studies.
- Other conditions deemed unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
N
NaXin Di
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here