NCT07097740

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Mitrassist Lifesciences Limited Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• AORTIC VALVE DISEASES
• Mitral Valve Disease
• Aortic Stenosis
• Aortic Regurgitation
• Mitral Stenosis
• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Polymer Prosthetic Heart Valve	Surgical implantation of polymer prosthetic valve.

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: China