At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THVdevice
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.
A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
In Brief
A clinical study evaluating SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV for Aortic Valve Stenosis. Completed, enrolled 100 participants across 6 sites in 2 countries.
Detailed Summary
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesCanada, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartJun 2018
Primary CompletionDec 2019
Study CompletionJan 2025
TodayJul 2026
First PostedMar 20, 2018
Enrollment StartJun 1, 2018
Primary CompletionDec 23, 2019
Study CompletionJan 21, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.3 years ago
Interventions
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THVdevice
Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.