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New heart valve fix could spare patients from Open-Heart surgery

NCT ID NCT05061004

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 3 times

Summary

This study tests a new device called the Cephea Mitral Valve System for people with a leaky or narrowed mitral heart valve. The goal is to see if it is safe and works well for patients who are not good candidates for open-heart surgery. About 50 people will get the device and be followed for 30 days to check for serious problems and whether the valve leak is reduced.

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 90 people

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

Started

Apr 2022

Expected to finish

Mar 2031

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.

Key Inclusion Criteria: * Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria. * LVEF ≥ 30% * In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery. Key Exclusion Criteria: * Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. * Need for emergent or urgent surgery.

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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 regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny General Hospital - ASRI

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Saint Thomas

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Ascension Via Christi Hospitals Wichita

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Atrium Health - Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Banner-University Medical Center Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • IUCPQ-ULaval

    WITHDRAWN

    Québec, Quebec, G1V 4G5, Canada

  • Institut de Cardiologie de Montreal

    COMPLETED

    Montreal, Quebec, Canada

  • Los Robles Regional Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • New York-Presbyterian/Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • University of California - Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Michigan - Davis Medical Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt Heart & Vascular Institute

    RECRUITING

    Nashville, Tennessee, 37208, United States

More trials for these conditions

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