Home › Mitral Valve Insufficiency › NCT05061004
Cephea Early Feasibility Study
Recruiting
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) 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. Key Exclusion Criteria: * Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. * Need for emergent or urgent surgery.
About the study
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.
What is being tested
- Cephea Mitral Valve System (device)
Sponsor: Abbott Medical Devices · Participants: 90 · Started: Apr 28, 2022
Contact the study team
- Leslie Centeno · Phone: +1 818-294-3041
Official record on ClinicalTrials.gov — NCT05061004
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.