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RECRUITING Not applicable ClinicalTrials.gov

Cephea Early Feasibility Study

Sponsor: Abbott Medical Devices • ClinicalTrials.gov ID: NCT05061004

Registry updated: 2026-09-11
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Description

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.

Interventions

  • Cephea Mitral Valve System (Device)
    Transcatheter mitral valve replacement

Eligibility criteria

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.

Conditions

Mitral Regurgitation

Locations

  • Banner-University Medical Center Phoenix — Phoenix, Arizona, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • University of California - Davis Medical Center — Sacramento, California, United States
  • Los Robles Regional Medical Center — Thousand Oaks, California, United States
  • Emory University Hospital — Atlanta, Georgia, United States
  • Piedmont Heart Institute — Atlanta, Georgia, United States
  • Northwestern Memorial Hospital — Chicago, Illinois, United States
  • Ascension Via Christi Hospitals Wichita — Wichita, Kansas, United States
  • University of Michigan - Davis Medical Center — Ann Arbor, Michigan, United States
  • Minneapolis Heart Institute — Minneapolis, Minnesota, United States
  • New York-Presbyterian/Columbia University Medical Center — New York, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Atrium Health - Carolinas Medical Center — Charlotte, North Carolina, United States
  • The Cleveland Clinic Foundation — Cleveland, Ohio, United States
  • Allegheny General Hospital - ASRI — Pittsburgh, Pennsylvania, United States
  • Ascension Saint Thomas — Nashville, Tennessee, United States
  • Vanderbilt Heart & Vascular Institute — Nashville, Tennessee, United States
  • Houston Methodist — Houston, Texas, United States
  • Sentara Norfolk General Hospital — Norfolk, Virginia, United States
  • Swedish Medical Center — Seattle, Washington, United States
  • Institut de Cardiologie de Montreal — Montreal, Quebec, Canada
  • IUCPQ-ULaval — Québec, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record