Actively Recruiting
Cephea Early Feasibility Study
Led by Abbott Medical Devices · Updated on 2026-04-08
50
Participants Needed
22
Research Sites
461 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cephea Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mitral valve disease causing mitral regurgitation Grade III or higher and/or severe mitral valve stenosis with valve area 1.5 cm² or less according to American Society of Echocardiography criteria
- Left ventricular ejection fraction (LVEF) of 30% or greater
- Transcatheter therapy judged by the Site Heart Team to be more appropriate than open heart surgery
You will not qualify if you...
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function
- Need for emergent or urgent surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Not Yet Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California - Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
4
Los Robles Regional Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
5
Emory University Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
7
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
8
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States, 67214
Actively Recruiting
9
University of Michigan - Davis Medical Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
11
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
13
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
14
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
16
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
17
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States, 37208
Actively Recruiting
18
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
19
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
20
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
21
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Completed
22
IUCPQ-ULaval
Québec, Quebec, Canada, G1V 4G5
Withdrawn
Research Team
L
Leslie Centeno
CONTACT
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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