Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Last updated: January 24, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Heart Disease

Treatment

MITRIS RESILIA Mitral Valve, Model 11400M

Clinical Study ID

NCT05526560
2022-09
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older at the time of informed consent

  • Has a dysfunctional native or prosthetic mitral valve and requires mitral valvereplacement surgery

  • Provides written informed consent

  • Willingness to follow protocol requirements

Exclusion

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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: MITRIS RESILIA Mitral Valve, Model 11400M
Phase:
Study Start date:
January 11, 2023
Estimated Completion Date:
December 31, 2035

Study 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.

Connect with a study center

  • St. Paul's Hospital and Vancouver General Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • London Health Sciences Centre, University Hospital (LHSC)

    London, Ontario N6G 5G1
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montréal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec, QC G1V 4G5
    Canada

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545
    Germany

    Active - Recruiting

  • University Clinic Bonn

    Bonn, 53127
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum München

    München, 80636
    Germany

    Active - Recruiting

  • University of Alabama Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Piedmont Heart Institute

    Athens, Georgia 30606
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Ascension St. Vincent Heart Center

    Carmel, Indiana 46290
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27703
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Ascension Saint Thomas

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Tristar Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Mayo Clinic Health System - Eau Claire

    Eau Claire, Wisconsin 54703
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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