Active — Not RecruitingNot Applicable

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

United States504 participantsStarted 2023-01-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Freedom from valve related death or valve related reintervention

Timeframe: 1 year

Hemodynamic performance as measured by peak and mean gradient by echocardiography

Timeframe: 1 year

Trial details

NCT IDNCT05526560

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-01

View on ClinicalTrials.gov More Mitral Stenosis trials