Trials / Completed
CompletedNCT03699345
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 87 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Detailed description
A prospective, international, single arm, multi-center post market clinical follow-up study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Aortic Valve Replacement (TAVR) | TAVR with the Edwards CENTERA THV System and accessories |
Timeline
- Start date
- 2019-01-07
- Primary completion
- 2019-08-14
- Completion
- 2024-08-20
- First posted
- 2018-10-09
- Last updated
- 2024-11-04
Locations
11 sites across 6 countries: Denmark, France, Germany, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03699345. Inclusion in this directory is not an endorsement.