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

May 19, 2026 updated by: Edwards Lifesciences

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
504

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada, QC G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec - Université 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from valve related death or valve related reintervention
Time Frame: 1 year
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
Time Frame: 1 year
Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early rates of major cardiac events
Time Frame: 0 to 30 days
Early (<=30 days) rates of major cardiac events
0 to 30 days
Late linearized rates of major cardiac events
Time Frame: >30 days and up through 10 years post implant
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
Time Frame: Annually up to 10 years post implant
Functional improvement from baseline for NYHA Class
Annually up to 10 years post implant
Improvement from baseline for Quality of Life
Time Frame: 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)
1, 3, 5, 8, and 10 years post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gorav Ailawadi, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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