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Cephea South America Feasibility Study
Sponsor: Abbott Medical Devices
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-06-17
Completion Date
2028-09
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Cephea Mitral Valve System
Cephea Mitral Valve System
Locations (3)
Instituto do Coracao (InCor) - HCFMUSP
São Paulo, Brazil
Instituto Nacional del Torax
Santiago, Chile
Hospital Clinico San Borja Arriarán
Santiago, Chile