Cephea Early Feasibility Study
Purpose
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.
Condition
- Mitral Regurgitation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. - Need for emergent or urgent surgery.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System |
|
Recruiting Locations
Vanderbilt Heart & Vascular Institute
Nashville 4644585, Tennessee 4662168 37208
Nashville 4644585, Tennessee 4662168 37208
More Details
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices