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Collecting real-world outcomes of the MITRIS RESILIA Mitral Valve

A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Observational Edwards Lifesciences · NCT05526560

This study is trying to see how safe and effective the MITRIS RESILIA Mitral Valve is for patients who need mitral valve replacement surgery.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT05526560 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in patients requiring mitral valve replacement. It will involve up to 500 participants who have a dysfunctional native or prosthetic mitral valve and will undergo surgery. The study is designed as a prospective, single-arm, multicenter global initiative, focusing on both acute and long-term clinical outcomes. Participants will be monitored to assess the valve's effectiveness and safety in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a dysfunctional native or prosthetic mitral valve requiring replacement surgery.

Not a fit: Patients with active endocarditis, severe renal disease, or a very high predicted risk of mortality may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the MITRIS RESILIA Mitral Valve for patients with mitral valve issues.

How similar studies have performed: Other studies have shown success in collecting real-world data on valve replacements, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 18 years or older at the time of informed consent
* Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
* Provides written informed consent
* Willingness to follow protocol requirements

Exclusion Criteria:

* Active endocarditis 3 months prior to the procedure
* Stage 4 renal disease or requiring dialysis
* Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
* High predicted risk of mortality prior to procedure

  * Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of \> 8 or
  * Surgeon estimated risk of mortality of \> 8

Where this trial is running

Birmingham, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral StenosisMitral Valve InsufficiencyMitral Valve Replacement
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.