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AltaValve Pivotal Trial
Sponsor: 4C Medical Technologies, Inc.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-09-03
Completion Date
2031-09
Last Updated
2025-05-02
Healthy Volunteers
No
Conditions
Interventions
AltaValve 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