Mitral Stenosis, Mitral Valve Insufficiency
Conditions
Keywords
Mitral Valve Replacement
Brief 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.
Detailed 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.
Interventions
DEVICEMITRIS RESILIA Mitral Valve, Model 11400M
Replacement of mitral valve with MITRIS RESLIA Mitral Valve
Sponsors
Edwards Lifesciences
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from valve related death or valve related reintervention | 1 year | Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee |
| Hemodynamic performance as measured by peak and mean gradient by echocardiography | 1 year | Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early rates of major cardiac events | 0 to 30 days | Early (\<=30 days) rates of major cardiac events |
| Late linearized rates of major cardiac events | >30 days and up through 10 years post implant | Linearized rates of late (\>30 days) major cardiac events |
| Functional improvement from baseline for New York Heart Association (NYHA) Class | Annually up to 10 years post implant | Functional improvement from baseline for NYHA Class |
| Improvement from baseline for Quality of Life | 1, 3, 5, 8, and 10 years post implant | Improvement from baseline for Quality of Life as measured by the Short Form (36) Health Survey (SF-36v2) (0-100 scale, with a higher score indicating less disability) |
Countries
Canada, Germany, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORGorav Ailawadi, MD
University of Michigan
Outcome results
None listed