Cephea Early Feasibility Study
Status: Recruiting
Location: See all (14) 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
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
University of California - Davis Medical Center
RECRUITING
Sacramento
Georgia
Piedmont Heart Institute
RECRUITING
Atlanta
Kansas
Cardiovascular Research Institute of Kansas
RECRUITING
Wichita
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Minneapolis Heart Institute
RECRUITING
Minneapolis
North Carolina
Carolinas Medical Center
RECRUITING
Charlotte
New York
Montefiore Medical Center
RECRUITING
Bronx
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Tennessee
St. Thomas Hospital
RECRUITING
Nashville
Texas
The Methodist Hospital
RECRUITING
Houston
Virginia
Sentara Norfolk General Hospital
WITHDRAWN
Norfolk
Other Locations
Canada
Institut de Cardiologie de Montreal
ACTIVE_NOT_RECRUITING
Montreal
Institut de Cardiologie de Quebec
ACTIVE_NOT_RECRUITING
Quebec
Contact Information
Primary
Shimako Nakajima
shimako.nakajima@abbott.com
+1 408-845-0873
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