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
Qualifiers
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
Treatments tested in this trial
- Cephea Mitral Valve System
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
22Canada
Institut de Cardiologie de Montreal MontrealQuebec, Canada
IUCPQ-ULavalG1V 4G5, QuébecQuebec, Canada
United States
Arizona
Banner-University Medical Center Phoenix85006, Phoenix United States
California
Cedars-Sinai Medical Center90048, Los Angeles United States
Sponsors and collaborators
Abbott Medical Devices
Lead sponsor
Source ClinicalTrials.gov