Cephea Early Feasibility Study
Cephea Early Feasibility 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.
Not Available
Early Phase I
Not Available
Not Available
Goel, Kashish
National
Vanderbilt University
08-06-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Mitral valve disease resulting in mitral regurgitation (MR Grade III) and/or severe mitral valve stenosis (mitral valve area 1.5cm) 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.
Mitral valve disease resulting in mitral regurgitation (MR Grade III) and/or severe mitral valve stenosis (mitral valve area 1.5cm) 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.
