Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Conditions
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Mitral Stenosis, Mitral Valve Insufficiency

Intervention / Treatment
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* Device: MITRIS RESILIA Mitral Valve, Model 11400M


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients requiring replacement of their native or prosthetic mitral valve<br>Patients requiring replacement of their native or prosthetic mitral valve | Device: MITRIS RESILIA Mitral Valve, Model 11400M<br>* Replacement of mitral valve with MITRIS RESLIA Mitral Valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from valve related death or valve related reintervention | Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee | 1 year | 
| Hemodynamic performance as measured by peak and mean gradient by echocardiography | Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early rates of major cardiac events | Early (<=30 days) rates of major cardiac events | 0 to 30 days | 
| Late linearized rates of major cardiac events | Linearized rates of late (>30 days) major cardiac events | >30 days and up through 10 years post implant | 
| Functional improvement from baseline for New York Heart Association (NYHA) Class | Functional improvement from baseline for NYHA Class | Annually up to 10 years post implant | 
| Improvement from baseline for Quality of Life | 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) | 1, 3, 5, 8, and 10 years post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve Replacement