Cephea Early Feasibility Study
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.
• LVEF ≥ 30%
• In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
Locations
United States
Arizona
Banner-University Medical Center Phoenix
NOT_YET_RECRUITING
Phoenix
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
University of California - Davis Medical Center
RECRUITING
Sacramento
Los Robles Regional Medical Center
RECRUITING
Thousand Oaks
Georgia
Emory University Hospital
RECRUITING
Atlanta
Piedmont Heart Institute
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Kansas
Via Christi Regional Medical Center - St. Francis Campus
RECRUITING
Wichita
Michigan
University of Michigan - Davis Medical Center
RECRUITING
Ann Arbor
Minnesota
Minneapolis Heart Institute
RECRUITING
Minneapolis
North Carolina
Atrium Health - Carolinas Medical Center
RECRUITING
Charlotte
New York
New York-Presbyterian/Columbia University Medical Center
RECRUITING
New York
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
Allegheny General Hospital - ASRI
RECRUITING
Pittsburgh
Tennessee
Ascension Saint Thomas
RECRUITING
Nashville
Vanderbilt Heart & Vascular Institute
RECRUITING
Nashville
Texas
Houston Methodist
RECRUITING
Houston
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Canada
Institut de Cardiologie de Montreal
COMPLETED
Montreal
IUCPQ-ULaval
WITHDRAWN
Québec
Contact Information
Primary
Leslie Centeno
leslie.centeno@abbott.com
+1 818-294-3041
Backup
Clinical Project Manager
Cephea_FS@abbott.com
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2031-03-01
Participants
Target number of participants: 50
Treatments
Experimental: Treatment
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices