SAPIEN 3 Ultra System PMCF
NCT04555967 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-04-15
Summary
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Conditions
- Aortic Valve Stenosis
Interventions
- DEVICE
-
SAPIEN 3 Ultra System
Transcatheter aortic valve implantation
Sponsors & Collaborators
-
Edwards Lifesciences
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-30
- Primary Completion
- 2021-09-24
- Completion
- 2026-11-30
- FDA Device
- Yes
Countries
- Austria
- Canada
- Denmark
- Finland
- Germany
- Italy
- Netherlands
- United Kingdom
Study Locations
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