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New registry tracks mitral valve patients to shape future heart treatments

NCT ID NCT07069673

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study is a registry that collects information from 1,000 people with symptomatic mitral valve disease, including mitral regurgitation and stenosis. The goal is to better understand how correcting these heart valve problems with a less invasive procedure called transcatheter mitral valve replacement (TMVR) affects patient outcomes. The data will help guide future product development and treatment strategies.

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

About 1,000 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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

This registry will enroll subjects over 18 years of age of all genders with symptomatic mitral valve disease including those with mitral regurgitation, mitral stenosis, and mixed mitral valve disease, who are candidates for transcatheter mitral valve replacement.

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: 1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis. 2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV. 3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure. 4. Age 18 years or older at time of consent. 5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent. Exclusion Criteria: 1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. 2. Subject is undergoing dialysis or experiencing chronic renal failure 3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use 4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months. 5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease mitral valve disorder mitral valve insufficiency mitral valve stenosis

As listed by the trial registrant

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

Mitral annulus calcification Mitral regurgitation Mitral stenosis Mitral valve (MV) regurgitation Mitral valve disease Mitral valve replacement Transcatheter valve replacement

How to take part

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

  1. The places running it

    24 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 St. Vincent

    RECRUITING

    Indianapolis, Indiana, 46240, 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

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Los Robles Regional Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Phoenix Cardiovascular Research Group

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Providence St. Patrick Hospital

    RECRUITING

    Missoula, Montana, 59802, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St. Francis Hospital

    RECRUITING

    Roslyn, New York, 11576, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UTHealth Memorial Hermann

    RECRUITING

    Houston, Texas, 77030, United States

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Vanderbilt Heart & Vascular Institute

    RECRUITING

    Nashville, Tennessee, 37232, United States

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