Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Mitral Valve Insufficiency Clinical Trial

— MOMENTIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05526560
• Other study ID #: 2022-09
• Status: Active, not recruiting
• Start date: January 11, 2023
• Est. completion date: December 2035

Study information

• Verified date: June 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2035
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Mitral Stenosis
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

Intervention

Device:
• MITRIS RESILIA Mitral Valve, Model 11400M
Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital (LHSC)	London	Ontario
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Québec
Canada	St. Paul's Hospital and Vancouver General Hospital	Vancouver	British Columbia
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Athens	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Ascension St. Vincent Heart Center	Carmel	Indiana
United States	Duke University Medical Center	Durham	North Carolina
United States	Mayo Clinic Health System - Eau Claire	Eau Claire	Wisconsin
United States	University of Southern California	Los Angeles	California
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Ascension Saint Thomas	Nashville	Tennessee
United States	Tristar Centennial Medical Center	Nashville	Tennessee
United States	Columbia University Irving Medical Center	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	Washington University Barnes-Jewish Hospital	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Early rates of major cardiac events	Early (<=30 days) rates of major cardiac events	0 to 30 days
Secondary	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
Secondary	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
Secondary	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