Cephea South America Feasibility Study
Recruiting
N/A
Interventional Study
Mitral Regurgitation
Mitral Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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About This Trial
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.
Trial Locations
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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) per American Society of Echocardiography criteria
* LVEF ≥ 30%
* In the judgement of the Site Heart Team, transcatheter therapy is deeme…
Contacts