Actively Recruiting
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
Led by Mitrassist Lifesciences Limited Co., Ltd. · Updated on 2025-07-31
10
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
M
Mitrassist Lifesciences Limited Co., Ltd.
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement. The main question it aims to answer is: \-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation? Participants will undergo: * Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group). * Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.
CONDITIONS
Official Title
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults requiring surgical replacement of either mitral or aortic valve
- Capable of undergoing cardiopulmonary bypass
- Able to tolerate anticoagulation therapy
- Able to understand study purpose, willing to provide informed consent and comply with follow-up
You will not qualify if you...
- History of previous cardiac valve surgery or percutaneous valve replacement, except Percutaneous Balloon Mitral Valvuloplasty
- Need for urgent or emergency cardiac surgery
- Planned combined valve procedures including simultaneous aortic and mitral valve surgery
- Scheduled coronary artery bypass graft during same admission
- Expected need for additional non-valve cardiac surgery within 12 months
- Active systemic infection such as pneumonia or infective endocarditis
- Intracardiac thrombus detected on imaging
- Stroke or transient ischemic attack within past 3 months
- Myocardial infarction, unstable coronary syndrome, or coronary revascularization within past 3 months
- Severe comorbidities with life expectancy under 12 months, including advanced liver disease, end-stage cancer, or severe lung disease
- Participation in another interventional clinical trial involving investigational devices or drugs
- Anatomical risks including ascending aortic aneurysm ≥50 mm, bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk imaging features
- Left ventricular ejection fraction ≤35%, indicating severe heart dysfunction
- Severe kidney failure or need for chronic dialysis
- Coagulation disorders or active bleeding, including INR >1.5 without anticoagulation
- Blood abnormalities such as low hematocrit, low hemoglobin, low platelet count, or abnormal white blood cell counts
- History of substance abuse, alcoholism, or significant psychiatric illness impeding study compliance
- Unsuitable valve anatomy or cardiac structure before or during surgery
- Known allergy to polyurethane, polyester, or sulfonate-based materials in the valve
- Withdrawal from study after valve implantation (no re-enrollment allowed)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
L
Lai Wei, MD
CONTACT
C
Chunming Du, Medical Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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