Cephea South America Feasibility Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
Instituto do Coracao (InCor) - HCFMUSP
RECRUITING
São Paulo
Chile
Hospital Clinico San Borja Arriarán
RECRUITING
Santiago
Instituto Nacional del Torax
RECRUITING
Santiago
Contact Information
Primary
Jennifer Studt
jennifer.studt@abbott.com
314-616-2790
Backup
Clinical Project Manager
Cephea_FS@abbott.com
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2028-09
Participants
Target number of participants: 20
Treatments
Experimental: Cephea TMVR
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices