At a glance
ClinicalIndex Comparison RecordN/AActive· 1,000 enrolled
Drug / intervention
SAVR +1 moreprocedure
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, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
In Brief
A clinical study evaluating SAVR and SAPIEN 3 THV for Aortic Stenosis. Active but no longer recruiting, targeting 1,000 participants across 77 sites in 5 countries.
Detailed Summary
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
CountriesAustralia, Canada, Japan, New Zealand, United States
Collaborators--
Timeline
N/AActive
201620172018201920202021202220232024202520262027202820292030
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionNov 2020
TodayJul 2026
Study CompletionDec 2029
First PostedFeb 5, 2016
Enrollment StartMar 1, 2016
Primary CompletionNov 16, 2020
Study CompletionDec 1, 2029
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.4 years ago
Interventions
SAVRprocedure
SAVR with a commercially available bioprosthetic valve.
SAPIEN 3 THVdevice
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System