Actively Recruiting
Safety and Feasibility Study of the MitraFix4 Transcatheter Mitral Valve System for Adults with Severe Mitral Regurgitation at High Surgical Risk
Led by Mitrassist Lifesciences Limited Co., Ltd. · Updated on 2026-03-30
5
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the MitraFix4 Transcatheter Mitral Valve System in adults with severe mitral regurgitation who are at high risk for traditional open-heart surgery. This early feasibility trial aims to determine if the device is safe, can be successfully implanted, and helps reduce the valve leak to improve daily life. The study is led by MitralAssist Lifesciences Limited Co., Ltd and focuses on patients with moderate-to-severe or severe mitral valve leakage. Participants will receive the MitraFix device implanted via a small tube inserted through a vein in the leg using a transfemoral-transseptal approach. The study involves only one treatment group where all participants receive the device. The device placement is assessed for success during the procedure and after 30 days. Valve performance and other health measures are followed for up to 12 months after implantation. During the study, participants will visit the clinic for heart tests, walking tests, and health evaluations for up to one year after the procedure. Researchers will monitor device success, valve function, changes in heart failure symptoms, quality of life, exercise capacity, hospitalizations, and any adverse events. Follow-up includes assessments such as the New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ), and 6-minute walk distance to evaluate the device's impact on participants' health and daily living.
CONDITIONS
Brief 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 (\u22653+) mitral regurgitation
- Age 18 years or older
- High risk for traditional open-heart surgery, defined by STS mortality risk \u2265 8%, or presence of 2 or more frailty indices, or 2 or more major organ dysfunctions that cannot improve post-operatively, or other comorbidities making surgery unsuitable
- Anatomically suitable for MitraFix system implantation via transfemoral-transseptal approach
- Able to understand the 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, or unsuitable mitral valve anatomy for device implantation
- High risk of left ventricular outflow tract obstruction not avoidable by procedure
- Previous mitral valve implants (bioprosthetic, mechanical valves, annuloplasty rings)
- Active infection such as infective endocarditis
- Stroke or transient ischemic attack within 90 days
- Severe untreated coronary artery disease, recent myocardial infarction, or coronary stent placement within 90 days
- Severe pulmonary hypertension with resting PASP > 70 mmHg
- Severe right ventricular dysfunction (TAPSE < 17 mm)
- Other valve or great vessel diseases needing surgery
- Left ventricular ejection fraction below 30%
- Extreme frailty or shock requiring circulatory support
- Recent cardiac device implantation within 30 days
- Chronic dialysis or severe renal impairment unable to undergo dialysis
- Blood disorders or contraindications to anticoagulant therapy
- Intracardiac mass or thrombus
- Contraindications to transesophageal echocardiography
- Severe allergy to device materials
- Life expectancy less than 12 months
- Pregnant or breastfeeding women
- Unsuitable for transfemoral-transseptal approach
- Participation in another interfering clinical study within 3 months
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and immediate recovery period
Participants receive the MitraFix® Transcatheter Mitral Valve System implanted via a transfemoral-transseptal approach.
1 procedure visit and approximately 1 post-procedure hospital stay
Duration - Up to 12 months post-procedure
Participants are monitored for device success, valve performance, heart function, quality of life, and adverse events after the procedure.
Regular follow-up visits over 12 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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