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Cephea Early Feasibility Study
Sponsor: Abbott Medical Devices
Summary
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-04-28
Completion Date
2031-03-01
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Cephea Mitral Valve System
Transcatheter mitral valve replacement
Locations (22)
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
University of Michigan - Davis Medical Center
Ann Arbor, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Houston Methodist
Houston, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
IUCPQ-ULaval
Québec, Quebec, Canada