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Active Not Recruiting
NCT07244939
Cephea South America Feasibility Study
Conditions: Mitral Regurgitation, Mitral Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Abbott Medical Devices
Location: Instituto do Coracao (InCor) - HCFMUSP São Paulo
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 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 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
Source: ClinicalTrials.gov (NCT07244939). StuddyBuddy aggregates publicly available trial information.
