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Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve

NCT07097740 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Polymer Prosthetic Heart Valve

Surgical implantation of polymer prosthetic valve.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Mitrassist Lifesciences Limited Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07097740 on ClinicalTrials.gov