Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve (MOMENTIS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Valve Insufficiency; Mitral Stenosis
• Intervention / Treatment: Device: MITRIS RESILIA Mitral Valve, Model 11400M

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 Type: Observational
• Enrollment (Actual): 504

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, QC G1V 4G5
    • Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital and Vancouver General Hospital
  • Ontario
    • London, Ontario, Canada, N6G 5G1
      • London Health Sciences Centre, University Hospital (LHSC)
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
• Germany
  • Augsburg, Germany, 86156
    • Universitätsklinikum Augsburg
  • Bad Neustadt an der Saale, Germany, 97616
    • Rhoen-Klinikum Campus Bad Neustadt
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW
  • Bonn, Germany, 53127
    • University Clinic Bonn
  • Bremen, Germany, 28277
    • Klinikum Links der Weser
  • München, Germany, 80636
    • Deutsches Herzzentrum München
• United Kingdom
  • Cambridge, United Kingdom, SE5 9RS
    • Royal Papworth Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SE1 7EH
    • St. Thomas Hospital
  • London, United Kingdom, SW1X 7HY
    • Cleveland Clinic London
• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Heart Institute
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Ascension St. Vincent Heart Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University Barnes-Jewish Hospital
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Presbyterian Shadyside
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical Center
    • Nashville, Tennessee, United States, 37205
      • Ascension Saint Thomas
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring replacement of their native or prosthetic mitral valve

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients requiring replacement of their native or prosthetic mitral valve	Device: MITRIS RESILIA Mitral Valve, Model 11400M; Replacement of mitral valve with MITRIS RESLIA Mitral Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early rates of major cardiac events	Early (<=30 days) rates of major cardiac events	0 to 30 days
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
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
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Gorav Ailawadi, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mitral Valve Replacement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency; Mitral Valve Stenosis; Investigative Techniques; Models, Theoretical; Models, Biological
• Other Study ID Numbers: 2022-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes