Actively Recruiting
A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve
Led by Mitrassist Lifesciences Limited Co., Ltd. · Updated on 2025-07-31
10
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the early feasibility, safety, and effectiveness of surgically implanting a polymer prosthetic heart valve in patients who need either mitral or aortic valve replacement. This exploratory study will include 10 patients, with 5 receiving the valve in the mitral position and 5 in the aortic position. The main focus is to measure valve-related complications such as thromboembolism, valve thrombosis, severe leaks, severe bleeding, and infections within 12 months after surgery. Participants will undergo surgical implantation of the polymer prosthetic valve in either the mitral or aortic position according to their group. Follow-up visits are scheduled at 30 days, between 3 to 6 months, and at 12 months after the operation to assess clinical outcomes. These assessments include echocardiographic evaluations and monitoring for clinical events related to the valve and heart function. During the study, participants will have multiple assessments including heart function classification, valve performance measurements like blood flow gradients and leakage severity, and quality of life questionnaires. Safety monitoring will cover all-cause mortality, reoperations, and valve function over the 12-month period. The study aims to provide data on initial device success and comprehensive safety outcomes, with total participation lasting at least one year following valve implantation.
CONDITIONS
Brief 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 (excluding Percutaneous Balloon Mitral Valvuloplasty)
- Requirement for urgent or emergency cardiac surgery
- Planned concurrent aortic valve surgery or combined valve procedure
- Scheduled coronary artery bypass graft during the same admission
- Anticipated need for additional non-valve cardiac surgery within 12 months
- Active systemic infection including pneumonia or infective endocarditis
- Intracardiac thrombus detected on imaging
- Stroke or transient ischemic attack within the prior 3 months
- Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months
- Severe comorbidities with expected life expectancy less than 12 months
- Participation in another interventional clinical trial involving investigational devices or drugs
- Anatomical risk factors such as ascending aortic aneurysm ≥50 mm or bicuspid aortic valve with ascending aorta ≥45 mm
- Left ventricular ejection fraction ≤35%
- Severe renal insufficiency or need for chronic dialysis
- Coagulopathy or active bleeding disorders
- Hematologic abnormalities below specified thresholds
- History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance
- Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure
- Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials
- Withdrawal from the study after valve implantation (not allowed to re-enroll)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo surgical implantation of the polymer prosthetic heart valve followed by immediate post-operative care.
1 surgical visit and daily in-hospital assessments
Duration - 12 months
Participants are monitored for valve-related complications and undergo safety and heart function assessments.
Regular follow-up visits over 12 months
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
C
Chunming Du, Medical Master
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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