RecruitingNCT07059793
MITRIS China Post Market Clinical Follow-up (PMCF) Study
Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population
Sponsor
Edwards Lifesciences
Enrollment
250 participants
Start Date
Jul 8, 2025
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- years or older at the time of informed consent
- Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- Provide signed written informed consent prior to the study participation
- Willingness to follow protocol requirements
Exclusion Criteria5
- Active endocarditis 3 months prior to the procedure
- Stage 4 renal disease or requiring dialysis (eGFR \< 30 is excluded)
- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) \> 8 or Surgeon estimated risk of mortality of \> 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)
- Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.
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Interventions
DEVICEMITRIS RESILIA Mitral Valve
Surgical replacement of native or prosthetic mitral valve.
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT07059793