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.
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
History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty [PBMV], which is permitted).
Requirement for urgent or emergency cardiac surgery.
Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).
Scheduled coronary artery bypass graft (CABG) during the same admission.
Parallel
Polymer Prosthetic Heart Valve
DeviceSurgical implantation of polymer prosthetic valve.
12-Month Incidence of Valve-related Complications
Evaluate the incidence of valve-related complications at 12 months post-operation, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis.
Immediate Device Success Rate
Proportion of participants achieving successful device implantation without intraoperative complications.
Valve Hemodynamic Performance 1 Mean Transvalvular Gradient at 12 months
Mean pressure gradient across the valve measured by echocardiography (unit: mmHg).
Valve Hemodynamic Performance2 Effective Orifice Area (EOA) at 12 months
Effective orifice area of the implanted valve measured by echocardiography (unit: cm²).
Safety Outcomes and Adverse Events
Incidence of safety-related events including all-cause mortality, all-cause reoperation, valve extraction, valve thrombosis, severe bleeding, severe perivalvular leak, structural and non-structural valve deterioration, hemolysis, endocarditis, and any other serious adverse events.
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Mitrassist Lifesciences Limited Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
