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MITRIS China Post Market Clinical Follow-up (PMCF) Study

NCT07059793 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-12-30

No results posted yet for this study

Summary

Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Conditions

  • Mitral Valve Replacement

Interventions

DEVICE

MITRIS RESILIA Mitral Valve

Surgical replacement of native or prosthetic mitral valve.

Sponsors & Collaborators

  • Edwards (Shanghai) Medical Products Co. Ltd.

    collaborator UNKNOWN

  • Kun Tuo Medical Research and Development (Beijing) Co. Ltd.

    collaborator UNKNOWN

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Wei Feng, Professor · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2028-12-31
Completion
2038-12-31
FDA Device
Yes

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 NCT07059793 on ClinicalTrials.gov