Abbott Cephea Mitral Valve Disease Registry
Eligible age
18+ yrs
Accepts
All genders
Locations
18 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.
Sponsor: Abbott Medical Devices
You may qualify if…
- ✓ 1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
- ✓ 2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
- ✓ 3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
- ✓ 4. Age 18 years or older at time of consent.
- ✓ 5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
You may not qualify if…
- ✕ 1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- ✕ 2. Subject is undergoing dialysis or experiencing chronic renal failure
- ✕ 3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- ✕ 4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
- ✕ 5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07069673 · last updated 2026-06-22