Cephea Mitral Valve System for symptomatic mitral valve disease in South America
Cephea South America Feasibility Study
This trial will try a new catheter-delivered Cephea mitral valve to treat adults with symptomatic mitral regurgitation or severe mitral stenosis who are judged better suited for catheter therapy than open-heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 3 sites (São Paulo and 2 other locations) |
| Trial ID | NCT07244939 on ClinicalTrials.gov |
What this trial studies
This is a multi-center feasibility effort using the Cephea Mitral Valve System implanted via a transcatheter approach in symptomatic patients with significant mitral regurgitation and/or severe mitral stenosis. The study aims to collect preliminary safety and effectiveness data after device implantation in patients considered more appropriate for transcatheter therapy than open-heart surgery. Key entry criteria include MR ≥ Grade III and/or mitral valve area ≤ 1.5 cm² and a left ventricular ejection fraction of 30% or greater, with exclusions for prior interventions that would interfere with the device or need for urgent surgery. Procedures are being performed at specialist cardiac centers in Brazil and Chile under the sponsorship of Abbott Medical Devices.
Who should consider this trial
Good fit: Ideal candidates are symptomatic adults with moderate-to-severe or severe mitral regurgitation (MR ≥ Grade III) and/or severe mitral stenosis (mitral valve area ≤ 1.5 cm²), LVEF ≥ 30%, and who the heart team deems better suited for transcatheter therapy than surgery.
Not a fit: Patients who have prior surgical or interventional treatments that would interfere with Cephea device delivery or function, those requiring urgent or emergent surgery, or those with LVEF below 30% or unsuitable anatomy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could relieve symptoms and valve dysfunction while avoiding open-heart surgery for patients who are better candidates for a catheter-based approach.
How similar studies have performed: Transcatheter mitral valve replacement and repair approaches have shown promising early results in selected patients, but the Cephea device itself is novel and is being tested in an early feasibility setting.
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
São Paulo and 2 other locations
- Instituto do Coracao (InCor) - HCFMUSP — São Paulo, Brazil (Recruiting)
- Instituto Nacional del Torax — Santiago, Chile (Recruiting)
- Hospital Clinico San Borja Arriarán — Santiago, Chile (Recruiting)
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.