Actively Recruiting
Cephea South America Feasibility Study
Led by Abbott Medical Devices · Updated on 2026-02-06
20
Participants Needed
3
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cephea South America Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with mitral valve disease causing mitral regurgitation grade III or higher and/or severe mitral stenosis with valve area 1.5 cm8 or less as per American Society of Echocardiography
- Left ventricular ejection fraction of 30% or higher
- Transcatheter therapy considered more appropriate than open heart surgery by the Site Heart Team
You will not qualify if you...
- Prior surgical or interventional treatments that interfere with the Cephea valve delivery or function
- Need for emergent or urgent surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Instituto do Coracao (InCor) - HCFMUSP
São Paulo, Brazil, 05403-900
Actively Recruiting
2
Instituto Nacional del Torax
Santiago, Chile, 8320000
Actively Recruiting
3
Hospital Clinico San Borja Arriarán
Santiago, Chile, 8360160
Actively Recruiting
Research Team
L
Leslie Centeno
CONTACT
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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