Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

N/AActive Not RecruitingNCT05526560

Edwards Lifesciences504 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

504

Conditions

Mitral Stenosis Mitral Valve Insufficiency

Interventions

MITRIS RESILIA Mitral Valve, Model 11400MDEVICE

Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 1 year

Secondary Outcomes

Early rates of major cardiac events

Early (\<=30 days) rates of major cardiac events

Time frame: 0 to 30 days

Late linearized rates of major cardiac events

Linearized rates of late (\>30 days) major cardiac events

Time frame: >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

Time frame: 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)

Time frame: 1, 3, 5, 8, and 10 years post implant

Data from ClinicalTrials.gov

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...and 24 more locations