Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve

Recruiting N/A Interventional Study
AORTIC VALVE DISEASES Mitral Valve Disease Aortic Stenosis Aortic Regurgitation Mitral Stenosis Mitral Regurgitation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Mitrassist Lifesciences Limited Co., Ltd. · Industry
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About This Trial
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 perivalvula…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteri…
Contacts

Lai Wei, MD

021-51371990

wei.lai@zs-hospital.sh.cn

CONTACT

Chunming Du, Medical Master

CONTACT