RecruitingNot ApplicableNCT06465745

ATLAS (AltaValve) Pivotal Trial

ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial


Sponsor

4C Medical Technologies, Inc.

Enrollment

450 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called AltaValve System. for people with mitral incompetence, mitral insufficiency, and other related conditions. The study is currently recruiting participants at 29 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAltaValve System.

Transcatheter Mitral Valve Replacement.


Locations(58)

Banner University Medical Center

Phoenix, Arizona, United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

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

Phoenix, Arizona, United States

TMC Healthcare

Tucson, Arizona, United States

Scripps Health

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Orange County Heart Institute & Research Center

Orange, California, United States

Sutter Bay Hospitals

San Francisco, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

Baptist Medical Center

Jacksonville, Florida, United States

NCH Healthcare System

Naples, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Wellstar Center for Cardiovascular Care

Atlanta, Georgia, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

MedStar Health Research Institute, Inc.

Baltimore, Maryland, United States

MedStar Health Research Institute, Inc.

Columbia, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

AHS Hospital Corp.

Morristown, New Jersey, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The Charlotte-Mecklenburg Hospital; Atrium Health

Charlotte, North Carolina, United States

East Carolina Heart Institute at East Carolina University

Greenville, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

South Oklahoma Heart Research, LLC.

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

St. Paul's Hospital

Vancouver, British Colombia, Canada

St. Michael's Unity Health Toronto

Toronto, Ontario, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

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

Marseille, France

Société d'Exploitation du Centre Cardiologique du Nord

Paris, France

Clinique Pasteur

Toulouse, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitatsklinikum Bonn

Bonn, Germany

University Hospital Cologne - Heart Center

Cologne, Germany

Cardiac Research GmbH; St.-Johannes-Hospital Dortmund

Dortmund, Germany

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Germany

University Hospital of the Ruhr University Bochum

Oeynhausen, Germany

Heart Center Trier

Trier, Germany

Universitiitsklinikum Ulm

Ulm, Germany

Onassis Cardiac Surgery Center

Athens, Greece

Univeristy Hospital of Ioannina

Ioannina, Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Uniwersyteckim Szpitalem Klinicznym

Poznan, Poland

Hospital Clinic de Barcelona

Barcelona, Spain

Fundación para la investigación biomédica del hospital clínico San Carlos

Madrid, Spain

Hospital Álvaro Cunqueiro

Vigo, Spain

View Full Details on ClinicalTrials.gov

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NCT06465745


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