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Can a new valve device fix a leaky heart without open surgery?

NCT ID NCT06465745

Disease control Sponsor: 4C Medical Technologies, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing a new device called the AltaValve System, which is placed inside the heart to replace a leaky mitral valve. The study includes adults with moderate-to-severe mitral regurgitation who are not suitable for surgery or a less invasive repair procedure. The goal is to see if the device is safe and can reduce the risk of death or heart failure hospitalizations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AltaValve System, a transcatheter mitral valve replacement device
What this could lead to
If successful, this device could offer a new treatment option for people with severe mitral regurgitation who cannot have surgery or other less invasive procedures, potentially reducing symptoms and hospitalizations.
What could go wrong
This is a pivotal trial, but the device is still being tested for safety and effectiveness. Risks include procedural complications, device failure, or the need for re-intervention. Results may not generalize to all patients.

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 450 people

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

Started

Sep 2024

Expected to finish

Sep 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.

Inclusion Criteria: * Age ≥ 18 years. * Symptomatic New York Heart Association (NYHA) class II-IV. * Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab. * Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team. Exclusion Criteria (Abbreviated List): * Inability to understand the trial or a history of non-compliance with medical advice. * Inability to provide signed Informed Consent Form (ICF). * History of any cognitive or mental health status that would interfere with participation in the trial. * Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)). * Female subjects who are pregnant or planning to become pregnant within the trial period. * Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications. * Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated. * Known hypersensitivity to contrast media that cannot be adequately medicated. * Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%. * Concurrent medical condition with a life expectancy of less than 12 months. * Transcatheter aortic repair or replacement within 90 days prior to the baseline required tests. * Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral incompetence Mitral insufficiency Mitral regurgitation Mitral valve incompetence Mitral valve regurgitation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites in 7 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • AHS Hospital Corp.

    RECRUITING

    Morristown, New Jersey, 07960, United States

    Contact Email: •••••@•••••

  • Abrazo Arizona Heart Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Banner University Medical Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baptist Medical Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cardiac Research GmbH; St.-Johannes-Hospital Dortmund

    RECRUITING

    Dortmund, Germany

  • Cardiovascular Institute of the South

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Centre Hospitalier Universitaire de Bordeaux

    RECRUITING

    Bordeaux, 33404, France

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, Germany

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31076, France

  • Dignity Health; St. Joseph's Hospital and Medical Center

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • East Carolina Heart Institute at East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

    Contact Email: •••••@•••••

  • Fundación para la investigación biomédica del hospital clínico San Carlos

    RECRUITING

    Madrid, Spain

  • Heart Center Trier

    RECRUITING

    Trier, Germany

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Álvaro Cunqueiro

    RECRUITING

    Vigo, Spain

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Interbalkan Medical Center of Thessaloniki

    RECRUITING

    Thessaloniki, Greece

  • L'Assistance Publique-Hôpitaux de Marseille (AP-HM)

    RECRUITING

    Marseille, 13554, France

  • Los Robles Hospital & Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • MedStar Health Research Institute, Inc.

    RECRUITING

    Baltimore, Maryland, 21218, United States

    Contact Email: •••••@•••••

  • MedStar Health Research Institute, Inc.

    RECRUITING

    Columbia, Maryland, 21044, United States

    Contact Email: •••••@•••••

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

    Contact Email: •••••@•••••

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • NCH Healthcare System

    RECRUITING

    Naples, Florida, 34102, United States

  • New York Presbyterian Hospital-Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Onassis Cardiac Surgery Center

    RECRUITING

    Athens, Greece

  • Orange County Heart Institute & Research Center

    RECRUITING

    Orange, California, 92868, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Saint Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

    Contact Email: •••••@•••••

  • Scripps Health

    RECRUITING

    La Jolla, California, 92037, United States

  • Société d'Exploitation du Centre Cardiologique du Nord

    RECRUITING

    Paris, France

  • South Oklahoma Heart Research, LLC.

    RECRUITING

    Oklahoma City, Oklahoma, 73135, United States

    Contact Email: •••••@•••••

  • St. Michael's Unity Health Toronto

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

    Contact Email: •••••@•••••

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Colombia, V6Z 2K5, Canada

  • Sutter Bay Hospitals

    RECRUITING

    San Francisco, California, 94107, United States

  • TMC Healthcare

    RECRUITING

    Tucson, Arizona, 85712, United States

    Contact Email: •••••@•••••

  • The Charlotte-Mecklenburg Hospital; Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28203, United States

    Contact Email: •••••@•••••

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • Univeristy Hospital of Ioannina

    RECRUITING

    Ioannina, Greece

  • Universitatsklinikum Bonn

    RECRUITING

    Bonn, Germany

  • Universitiitsklinikum Ulm

    RECRUITING

    Ulm, 50937, Germany

  • University Hospital Cologne - Heart Center

    RECRUITING

    Cologne, Germany

  • University Hospital of the Ruhr University Bochum

    RECRUITING

    Oeynhausen, Germany

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    RECRUITING

    Mainz, Germany

  • Uniwersyteckim Szpitalem Klinicznym

    RECRUITING

    Poznan, 60-355, Poland

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wellstar Center for Cardiovascular Care

    RECRUITING

    Atlanta, Georgia, 30060, United States

    Contact Email: •••••@•••••

  • William Beaumont Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

More trials for these conditions

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