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Cephea Early Feasibility Study

RecruitingNAAges 18 Years - anyAllAbbott Medical Devices
NCT05061004 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. * Need for emergent or urgent surgery.
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What it tests

  • Cephea Mitral Valve System
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Where

22 sites
Banner-University Medical Center Phoenix
Phoenix, United States
Cedars-Sinai Medical Center
Los Angeles, United States
University of California - Davis Medical Center
Sacramento, United States
Los Robles Regional Medical Center
Thousand Oaks, United States
Emory University Hospital
Atlanta, United States
Piedmont Heart Institute
Atlanta, United States
Northwestern Memorial Hospital
Chicago, United States
Ascension Via Christi Hospitals Wichita
Wichita, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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