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Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

NCT05526560 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 504

Last updated 2026-05-22

No results posted yet for this study

Summary

Collect real-world data 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 Stenosis
  • Mitral Valve Insufficiency

Interventions

DEVICE

MITRIS RESILIA Mitral Valve, Model 11400M

Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Gorav Ailawadi, MD · University of Michigan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2028-01-31
Completion
2035-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

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 NCT05526560 on ClinicalTrials.gov