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

NCT ID NCT06465745

Recruiting now Disease control Sponsor: 4C Medical Technologies, Inc. Source: ClinicalTrials.gov ↗

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.

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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

Contacts and locations

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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

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