Evaluating a new mitral valve system for patients with severe mitral valve disease
Cephea Early Feasibility Study
This study is testing a new mitral valve system to see if it can safely help patients with severe mitral valve disease who can't have traditional heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 22 sites (Phoenix, Arizona and 21 other locations) |
| Trial ID | NCT05061004 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the preliminary safety and effectiveness of the Cephea Mitral Valve System in treating symptomatic patients with mitral valve disease, specifically those with significant mitral regurgitation or severe mitral stenosis. The approach focuses on patients for whom transcatheter therapy is considered more suitable than traditional open heart surgery. Participants will be evaluated based on specific echocardiographic criteria and left ventricular ejection fraction. The study is designed to gather initial data on the device's performance in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include patients with mitral regurgitation of Grade III or higher or severe mitral stenosis who are not suitable for open heart surgery.
Not a fit: Patients requiring urgent surgery or those with prior surgical interventions that affect the valve delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a less invasive treatment option for patients suffering from severe mitral valve disease.
How similar studies have performed: Other studies have shown promise with transcatheter approaches for mitral valve disease, suggesting potential for success with this novel device.
Eligibility criteria
Show full inclusion / exclusion 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) 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.
Where this trial is running
Phoenix, Arizona and 21 other locations
- Banner-University Medical Center Phoenix — Phoenix, Arizona, United States (Not_yet_recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of California - Davis Medical Center — Sacramento, California, United States (Recruiting)
- Los Robles Regional Medical Center — Thousand Oaks, California, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Piedmont Heart Institute — Atlanta, Georgia, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Via Christi Regional Medical Center - St. Francis Campus — Wichita, Kansas, United States (Recruiting)
- University of Michigan - Davis Medical Center — Ann Arbor, Michigan, United States (Recruiting)
- Minneapolis Heart Institute — Minneapolis, Minnesota, United States (Recruiting)
- New York-Presbyterian/Columbia University Medical Center — New York, New York, United States (Recruiting)
- Montefiore Medical Center - Moses Campus — The Bronx, New York, United States (Recruiting)
- Atrium Health - Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Allegheny General Hospital - ASRI — Pittsburgh, Pennsylvania, United States (Recruiting)
- Ascension Saint Thomas — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt Heart & Vascular Institute — Nashville, Tennessee, United States (Recruiting)
- Houston Methodist — Houston, Texas, United States (Recruiting)
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
- Institut de Cardiologie de Montreal — Montreal, Quebec, Canada (Completed)
- IUCPQ-ULaval — Québec, Quebec, Canada (Withdrawn)
Study contacts
- Study coordinator: Leslie Centeno
- Email: leslie.centeno@abbott.com
- Phone: +1 818-294-3041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.