Actively Recruiting
Cephea South America Feasibility Study for Mitral Valve Disease Using the Cephea Mitral Valve System
Led by Abbott Medical Devices · Updated on 2026-02-06
20
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary safety and effectiveness of the Cephea Mitral Valve System in treating symptomatic patients with mitral valve disease, including mitral regurgitation, mitral stenosis, and mixed mitral valve disease. The study focuses on patients for whom transcatheter therapy is considered more suitable than open heart surgery. This feasibility study is sponsored by Abbott Medical Devices and involves adult participants aged 18 years and older. Participants will receive treatment using the Cephea Mitral Valve System, a device designed to address mitral valve issues via a minimally invasive transcatheter approach. The study does not involve a control group or placebo and is not blinded. The primary outcomes measured 30 days after implant include freedom from all-cause mortality and reduction of mitral regurgitation to Grade I or less. During the study, participants will be monitored for safety and treatment effectiveness. Evaluations include assessments of mitral valve function and survival status at 30 days post-implant. Follow-up will help researchers understand the device's impact on mitral valve disease symptoms and patient outcomes. The total duration of participation may vary depending on individual follow-up schedules and assessments.
CONDITIONS
Brief Title
Cephea South America Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with mitral valve disease causing mitral regurgitation Grade III or higher and/or severe mitral valve stenosis with valve area 1.5 cm² or less according to American Society of Echocardiography criteria
- Left ventricular ejection fraction (LVEF) of 30% or greater
- Transcatheter therapy deemed more appropriate than open heart surgery by the site heart team
You will not qualify if you...
- Prior surgical or interventional treatment that interferes with the delivery or function of the Cephea valve
- Need for emergent or urgent surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo implantation of the Cephea Mitral Valve System to treat mitral valve disease.
1 implantation visit (in-person)
Duration - Up to 30 days
Participants receive immediate post-operative care following valve implantation to monitor recovery and address any complications.
Approximately 4 to 6 follow-up visits (in-person)
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
C
Clinical Project Manager
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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