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Cephea South America Feasibility Study

StatusActive, Not Recruiting
PhaseNot applicable
Started2025-06-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
notable
Study Status, Contacts/Locations v2
Enrollment closed, study ongoing
Study sitesdetails revised at 3 of 3 sites
2026-02-05
minor
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields
2025-11-17
minor
Original filing
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 Details
NCT Number NCT07244939
Lead Sponsor Abbott Medical Devices
Conditions Mitral Regurgitation, Mitral Stenosis
Enrollment 20 participants
Start Date 2025-06-17
Primary Completion 2026-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-11