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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Lai Wei, MD
wei.lai@zs-hospital.sh.cn
021-51371990
Backup
Chunming Du, Medical Master
Time Frame
Start Date: 2025-06-27
Estimated Completion Date: 2027-06
Participants
Target number of participants: 10
Treatments
Experimental: Polymer Aortic Valve Replacement
Surgical implantation of polymer prosthetic valve in the aortic position.
Experimental: Polymer Mitral Valve Replacement
Surgical implantation of polymer prosthetic valve in the mitral position.
Sponsors
Leads: Mitrassist Lifesciences Limited Co., Ltd.
Collaborators: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov