Cephea South America Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function
Need for emergent or urgent surgery
Trial design
Design model
Single group
Treatments tested in this trial
Cephea Mitral Valve System
DeviceCephea Mitral Valve System
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cephea TMVRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from all-cause mortality
Primary Safety Endpoint
Time frame
30 days post implant2
Reduction of MR to ≤ Grade I
Primary Effectiveness Endpoint
Time frame
30 days post implantSponsors and contacts
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Source ClinicalTrials.gov