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New heart valve replacement offers hope for high-risk patients

NCT ID NCT02718001

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called the Edwards EVOQUE eos mitral valve replacement system. It is for people with a leaky mitral valve who are too high-risk for open-heart surgery. The study will check if the device is safe and works well by looking at complications, heart function, and walking ability. 123 participants will receive the new valve through a less invasive procedure.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 123 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2015

Expected to finish

Apr 2033

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.

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: * Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Patient is inoperable

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Conditions

The condition(s) this trial relates to.

follicular lymphoma gastroesophageal reflux disease mitral valve insufficiency Neoplasm Metastasis

As listed by the trial registrant

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

Mitral valve regurgitation (degenerative or functional)

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Emory University Hospital/Emory University Hospital Midtown

    Atlanta, Georgia, 30322, United States

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval

    Québec, G1V 4G5, Canada

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. Michael's Hospital

    Toronto, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, Canada

  • St. Vincent Heart Center

    Indianapolis, Indiana, 46260, United States

  • Sutter Mills-Peninsula

    Burlingame, California, 94010, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center

    Houston, Texas, 77030, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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