At a glance
ClinicalIndex Comparison RecordN/ACompleted· 500 enrolled
Drug / intervention
Transcatheter Aortic Valve Implantation (TAVI)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SAPIEN 3 Ultra EU Post-Market Observational Study
In Brief
An observational study evaluating Transcatheter Aortic Valve Implantation (TAVI) for Aortic Stenosis and Aortic Valve Stenosis. Completed, enrolled 500 participants across 37 sites in 10 countries.
Detailed Summary
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis, Aortic Valve Stenosis
CountriesAustria, Finland, France, Germany, Italy, Norway, Portugal, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedApr 2021
Primary CompletionJul 2024
TodayJul 2026
First PostedApr 27, 2021
Enrollment StartApr 20, 2021
Primary CompletionJul 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.2 years ago
Interventions
Transcatheter Aortic Valve Implantation (TAVI)device
Subjects will undergo TAVI