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 is a prospective, exploratory, single-center clinical study designed to assess the early feasibility and initial safety of an investigational polymer prosthetic heart valve. A total of 10 patients will be enrolled, with 5 patients assigned to the mitral valve replacement group and 5 patients to the aortic valve replacement group. Primary outcomes include the occurrence of valve-related complications within 12 months, such as thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis. Secondary outcomes include immediate device success rate, valve hemodynamic performance, comprehensive safety event evaluations (e.g., all-cause mortality, all-cause reoperation, valve extraction, and structural or non-structural valve dysfunction), cardiac functional classification (NYHA), and quality of life assessments (Kansas City Cardiomyopathy Questionnaire, KCCQ). Eligible participants are patients requiring mitral or aortic valve replacement, capable of undergoing extracorporeal circulation and anticoagulation therapy, and who have provided informed consent. Exclusion criteria include patients with prior valve replacement surgery (except transcatheter mitral valve edge-to-edge repair), urgent/emergency procedures, significant comorbidities (e.g., recent stroke or myocardial infarction, severe liver/kidney dysfunction, active infections), severe coagulation disorders, allergies to valve materials, substance abuse issues, psychiatric disorders, or anticipated life expectancy under 12 months. Patients who drop out after valve implantation will not be replaced.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Surgical implantation of polymer prosthetic valve.
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING12-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.
Time frame: 12 months post-operation
Immediate Device Success Rate
Proportion of participants achieving successful device implantation without intraoperative complications.
Time frame: Immediately post-operation
Valve Hemodynamic Performance 1 Mean Transvalvular Gradient at 12 months
Mean pressure gradient across the valve measured by echocardiography (unit: mmHg).
Time frame: 12 months post-operation
Valve Hemodynamic Performance2 Effective Orifice Area (EOA) at 12 months
Effective orifice area of the implanted valve measured by echocardiography (unit: cm²).
Time frame: 12 months post-operation
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.
Time frame: Up to 12 months post-operation
Cardiac Function Classification (NYHA)
Assess participants' cardiac function using New York Heart Association (NYHA) classification.
Time frame: 12 months post-operation
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score at 12 months
Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire measuring health status in heart failure patients, scored from 0 to 100, where higher scores indicate a better health status.
Time frame: 12 months post-operation
Valve Hemodynamic Performance 3 Paravalvular Leakage Severity at 12 months
Severity of paravalvular leakage (PVL) assessed by echocardiography, classified as None/Trace, Mild, Moderate, or Severe.
Time frame: 12 months post-operation
Chunming Du, Medical Master
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