Actively Recruiting
Abbott Cephea Mitral Valve Disease Registry to Collect Data on Patients with Symptomatic Mitral Valve Disease Eligible for Transcatheter Mitral Valve Replacement
Led by Abbott Medical Devices · Updated on 2026-05-12
1000
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting clinical data on adults with symptomatic mitral valve disease, including those with mitral regurgitation, mitral stenosis, or mixed mitral valve disease. This observational registry aims to better understand the effects of correcting mitral valve disease on health outcomes, especially for patients who might be candidates for Transcatheter Mitral Valve Replacement (TMVR). The gathered information may also help guide future regulatory decisions for the Cephea Mitral Valve System. Participants include symptomatic patients considered suitable for TMVR by their heart care team, favoring this approach over conventional surgery or other therapies. The study will follow patients from enrollment for up to two years to observe their clinical progress. There are no specific treatments or interventions assigned by the study since it is observational. During the study, participants' health data will be collected regularly to monitor their condition and outcomes related to mitral valve disease correction. Follow-up includes reviewing clinical status and treatment effects over the two-year period. Participants must consent to data collection and follow-up visits, allowing researchers to evaluate the impact of TMVR candidacy on their health over time.
CONDITIONS
Brief Title
Abbott Cephea Mitral Valve Disease Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic mitral valve disease causing mitral regurgitation and/or severe mitral valve stenosis
- New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV
- Heart team considers transcatheter therapy more appropriate than conventional surgery and TMVR more likely to succeed than TEER
- Age 18 years or older at time of consent
- Agreement to study requirements, follow-up data entry, and written informed consent provided
You will not qualify if you...
- Prior surgical or interventional treatment interfering with Cephea valve delivery or function
- Undergoing dialysis or chronic renal failure
- Chronic lung disease needing continuous home oxygen or chronic outpatient oral steroid use
- Comorbidities likely to result in life expectancy less than 12 months
- Pregnant or nursing, or planning pregnancy during follow-up period
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 - Up to 2 years
Participants with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement are observed over time to collect data related to their condition.
Periodic visits over 2 years
Trial Site Locations
Total: 22 locations
1
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Los Robles Regional Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
3
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Ascension St. Vincent
Indianapolis, Indiana, United States, 46240
Actively Recruiting
7
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States, 67214
Actively Recruiting
8
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
9
Providence St. Patrick Hospital
Missoula, Montana, United States, 59802
Actively Recruiting
10
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
11
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
12
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
13
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
15
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
16
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
18
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
19
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
20
UTHealth Memorial Hermann
Houston, Texas, United States, 77030
Actively Recruiting
21
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
22
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
C
Cephea Project Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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