Actively Recruiting
Cephea Early Feasibility Study of the Cephea Mitral Valve System for Symptomatic Mitral Valve Disease
Led by Abbott Medical Devices · Updated on 2026-04-08
50
Participants Needed
22
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the early safety and effectiveness of the Cephea Mitral Valve System for patients experiencing symptoms from mitral valve disease, including mitral regurgitation, mitral stenosis, or a combination of both. The study focuses on patients for whom a less invasive transcatheter treatment is considered more suitable than open heart surgery. The trial is sponsored by Abbott Medical Devices and is interventional in nature. Participants will receive the Cephea Mitral Valve System, which is a device designed for transcatheter mitral valve replacement. This study involves treating symptomatic patients with this device to evaluate its performance and safety. The primary outcomes measured are safety and effectiveness at 30 days after the implant procedure. Throughout the study, participants will be monitored for safety and effectiveness endpoints 30 days post-implant. The research team will evaluate heart function and valve performance, following patients closely to document any adverse events or improvements. The total duration of participation and follow-up details beyond 30 days are not specified in the summary.
CONDITIONS
Brief Title
Cephea Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Mitral valve disease with mitral regurgitation grade III or higher and/or severe mitral valve stenosis (mitral valve area 1.5 cm2) as per American Society of Echocardiography criteria
- Left ventricular ejection fraction of 30% or higher
- Heart team considers transcatheter therapy more appropriate than open heart surgery
You will not qualify if you...
- Prior surgical or interventional treatment interfering with 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive transcatheter mitral valve replacement using the Cephea Mitral Valve System.
1 procedure visit (in-person)
Duration - 30 days post implant
Participants are monitored for safety and effectiveness after the device implantation.
Approximately 3 follow-up visits
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
C
Clinical Project Manager
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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