Overview
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.
Description
MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
Eligibility
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