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New heart valve tested in global study to improve valve replacement outcomes

NCT ID NCT05526560

Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks how well the MITRIS RESILIA mitral valve works in real-world patients who need a new mitral valve due to narrowing or leakage. About 504 adults having valve replacement surgery will be followed for safety and performance, including valve function and major heart events. The goal is to confirm the valve's long-term benefits in everyday medical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

504 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients requiring replacement of their native or prosthetic mitral valve

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency mitral valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mitral stenosis Mitral valve insufficiency

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205, United States

  • Ascension St. Vincent Heart Center

    Carmel, Indiana, 46290, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Cleveland Clinic London

    London, SW1X 7HY, United Kingdom

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Deutsches Herzzentrum München

    München, 80636, Germany

  • Duke University Medical Center

    Durham, North Carolina, 27703, United States

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545, Germany

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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

    Québec, QC G1V 4G5, Canada

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Klinikum Links der Weser

    Bremen, 28277, Germany

  • London Health Sciences Centre, University Hospital (LHSC)

    London, Ontario, N6G 5G1, Canada

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Piedmont Heart Institute

    Athens, Georgia, 30606, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Rhoen-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, 97616, Germany

  • Royal Papworth Hospital

    Cambridge, SE5 9RS, United Kingdom

  • St. Paul's Hospital and Vancouver General Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • St. Thomas Hospital

    London, SE1 7EH, United Kingdom

  • Stanford University

    Palo Alto, California, 94305, United States

  • Tristar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232, United States

  • University Clinic Bonn

    Bonn, 53127, Germany

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Washington University Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.