At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,032 enrolled
Drug / intervention
TAVR Implantation with SAPIEN XT +1 moredevice
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.
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
In Brief
A clinical study evaluating TAVR Implantation with SAPIEN XT and SAVR Implantation for Symptomatic Severe Aortic Stenosis. Completed, enrolled 2,032 participants across 57 sites in 2 countries.
Detailed Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Severe Aortic Stenosis
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionJan 2016
Study CompletionJan 2024
TodayJul 2026
First PostedMar 14, 2011
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2016
Study CompletionJan 17, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.3 years ago
Interventions
TAVR Implantation with SAPIEN XTdevice
Operable Group with SAPIEN XT
SAVR Implantationdevice
Control Group