CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Aortic Valve Stenosis
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
A prospective, international, single arm, multi-center post market clinical follow-up study to monitor and review device performance and outcomes of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valv...
A prospective, international, single arm, multi-center post market clinical follow-up study to monitor and review device performance and outcomes of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Tracking Information
- NCT #
- NCT03699345
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Prof. Hermann Reichenspurner UKE Hamburg-Eppendorf - University Heart Center Principal Investigator: Prof.Dr. Stephan Windecker Inselspital, Klinik für Kardiologie
Get Well Soon