RecruitingNot ApplicableNCT05061004
Cephea Early Feasibility Study
Sponsor
Abbott Medical Devices
Enrollment
50 participants
Start Date
Apr 28, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) 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.
Exclusion Criteria2
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- Need for emergent or urgent surgery.
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Interventions
DEVICECephea Mitral Valve System
Transcatheter mitral valve replacement
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT05061004
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