Trials / Completed
CompletedNCT03988946
Cephea Transseptal Mitral Valve System FIH
Cephea Mitral Valve and Transseptal Delivery System FIH
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Cephea Valve Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Mitral Valve Replacement via Transseptal Access | The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2019-06-18
- Last updated
- 2020-01-23
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03988946. Inclusion in this directory is not an endorsement.