RecruitingNot ApplicableNCT06465745

AltaValve 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAltaValve System.

Transcatheter Mitral Valve Replacement.


Locations(29)

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

Sutter Bay Hospitals

San Francisco, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

MedStar Health Research Institute, Inc.

Columbia, Maryland, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, 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

University Hospitals Cleveland Medical Center

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

Universitatsklinikum Bonn

Bonn, Germany

University Hospital Cologne - Heart Center

Cologne, Germany

Cardiac Research GmbH; St.-Johannes-Hospital Dortmund

Dortmund, Germany

Heart Center Trier

Trier, Germany

Onassis Cardiac Surgery Center

Athens, Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

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

For the most up-to-date information, visit the official listing.

Visit

NCT06465745


Related Trials