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SAPIEN 3 Ultra System PMCF
Sponsor: Edwards Lifesciences
Summary
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Official title: SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2020-06-30
Completion Date
2026-11
Last Updated
2025-04-17
Healthy Volunteers
No
Conditions
Interventions
SAPIEN 3 Ultra System
Transcatheter aortic valve implantation
Locations (11)
Medizinische Universitaet Wien
Vienna, Austria
St. Paul's Hospital Vancouver
Vancouver, British Columbia, Canada
Aarhus University Hospital, Skejby
Aarhus, Denmark
Helsinki University Hospital
Helsinki, Finland
Charité - Universitätsmedizin Berlin
Berlin, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Universitares Herzzentrum Hamburg
Hamburg, Germany
Ospedale G. Pasquinucci
Massa, Italy
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Royal Victoria Hospital Belfast
Belfast, United Kingdom
King's College Hospital London
London, United Kingdom