Cephea Early Feasibility Study
ConditionMitral Regurgitation
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 and/or mean transmitral gradient ≥10 mmHg at normal heart rate) 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
DeviceTranscatheter mitral valve replacement
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Time frame
30 days post implant2
Primary Effectiveness Endpoint
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
Time frame
30 days post implantSponsors and contacts
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Source ClinicalTrials.gov