Trials / Recruiting
RecruitingNCT05061004
Cephea Early Feasibility Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cephea Mitral Valve System | Transcatheter mitral valve replacement |
Timeline
- Start date
- 2022-04-28
- Primary completion
- 2026-12-31
- Completion
- 2031-03-01
- First posted
- 2021-09-29
- Last updated
- 2026-04-08
Locations
22 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05061004. Inclusion in this directory is not an endorsement.