Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Last updated: October 27, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Not 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: 504
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

  • St. Paul's Hospital and Vancouver General Hospital

    Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
    Canada

    Site Not Available

  • London Health Sciences Centre, University Hospital (LHSC)

    London, Ontario N6G 5G1
    Canada

    Active - Recruiting

  • London Health Sciences Centre, University Hospital (LHSC)

    London 6058560, Ontario 6093943 N6G 5G1
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montréal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal 6077243, Quebec 6115047 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

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

    Québec 6325494, QC G1V 4G5
    Canada

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg 2954172, 86156
    Germany

    Site Not Available

  • Rhoen-Klinikum Campus Bad Neustadt

    Bad Neustadt, 97616
    Germany

    Site Not Available

  • Rhoen-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale 2953389, 97616
    Germany

    Site Not Available

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen 2953386, 32545
    Germany

    Site Not Available

  • University Clinic Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • University Clinic Bonn

    Bonn 2946447, 53127
    Germany

    Site Not Available

  • Klinikum Links der Weser

    Bremen, 28277
    Germany

    Site Not Available

  • Klinikum Links der Weser

    Bremen 2944388, 28277
    Germany

    Site Not Available

  • Deutsches Herzzentrum München

    München, 80636
    Germany

    Site Not Available

  • Deutsches Herzzentrum München

    München 2867711, 80636
    Germany

    Site Not Available

  • Royal Papworth Hospital

    Cambridge, SE5 9RS
    United Kingdom

    Site Not Available

  • Royal Papworth Hospital

    Cambridge 2653941, SE5 9RS
    United Kingdom

    Site Not Available

  • Cleveland Clinic London

    London, SW1X 7HY
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • St. Thomas Hospital

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Cleveland Clinic London

    London 2643743, SW1X 7HY
    United Kingdom

    Site Not Available

  • King's College Hospital

    London 2643743, SE5 9RS
    United Kingdom

    Site Not Available

  • St. Thomas Hospital

    London 2643743, SE1 7EH
    United Kingdom

    Site Not Available

  • 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

  • Hoag Memorial Hospital Presbyterian

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Stanford University

    Palo Alto 5380748, California 5332921 94305
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando 4167147, Florida 4155751 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

  • Piedmont Heart Institute

    Athens 4180386, Georgia 4197000 30606
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Site Not Available

  • Ascension St. Vincent Heart Center

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Ascension St. Vincent Heart Center

    Carmel 4255466, Indiana 4921868 46290
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University Barnes-Jewish Hospital

    St Louis 4407066, Missouri 4398678 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

    Completed

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27703
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 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

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • UPMC Presbyterian Shadyside

    Pittsburgh 5206379, Pennsylvania 6254927 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

  • Ascension Saint Thomas

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Site Not Available

  • Tristar Centennial Medical Center

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 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

  • Aurora St. Luke's Medical Center

    Milwaukee 5263045, Wisconsin 5279468 53215
    United States

    Site Not Available

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