Condition: AORTIC VALVE DISEASES · Mitral Valve Disease · Aortic Stenosis · Sponsor: Mitrassist Lifesciences Limited Co., Ltd.
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.
This description comes directly from the study's public registry record.
Lai Wei, MD · 021-51371990 · wei.lai@zs-hospital.sh.cn
Chunming Du, Medical Master
Always discuss trial participation with your own doctor first.
| Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07097740