Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Edwards Lifesciences
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
