RecruitingNot ApplicableNCT07097740

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

A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve


Sponsor

Mitrassist Lifesciences Limited Co., Ltd.

Enrollment

10 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Polymer Prosthetic Heart Valve for people with aortic valve diseases, aortic stenosis, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPolymer Prosthetic Heart Valve

Surgical implantation of polymer prosthetic valve.


Locations(1)

Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07097740


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