Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Recruiting

• Conditions: Mitral Valve Insufficiency; Mitral Stenosis
• Interventions: Device: MITRIS RESILIA Mitral Valve, Model 11400M

• Registration Number: NCT05526560
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-02
• Study Start: 2023-01-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2028-01
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients requiring replacement of their native or prosthetic mitral valve	MITRIS RESILIA Mitral Valve, Model 11400M	Patients requiring replacement of their native or prosthetic mitral valve

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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)
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
Early rates of major cardiac events	0 to 30 days	Early (\<=30 days) rates of 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

Trial Locations

Locations (36)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Klinikum Links der Weser; 🇩🇪 Bremen, Germany

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Ascension St. Vincent Heart Center; 🇺🇸 Carmel, Indiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic, Rochester; 🇺🇸 Rochester, Minnesota, United States

Washington University Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, 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

Tristar Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

Ascension Saint Thomas; 🇺🇸 Nashville, Tennessee, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Mayo Clinic Health System - Eau Claire; 🇺🇸 Eau Claire, Wisconsin, United States

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

St. Paul's Hospital and Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, 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

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Rhoen-Klinikum Campus Bad Neustadt; 🇩🇪 Bad Neustadt, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

University Clinic Bonn; 🇩🇪 Bonn, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

Royal Papworth Hospital; 🇬🇧 Cambridge, United Kingdom

St. Thomas Hospital; 🇬🇧 London, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Cleveland Clinic London; 🇬🇧 London, United Kingdom