At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,074 enrolled
Drug / intervention
TAVRdevice
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 3 Transcatheter Heart Valve Therapy for Intermediate Risk Patients
In Brief
A clinical study evaluating TAVR for Symptomatic Severe Aortic Stenosis. Completed, enrolled 1,074 participants across 51 sites.
Detailed Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Severe Aortic Stenosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
Primary CompletionNov 2015
First PostedJul 2017
Study CompletionOct 2024
TodayJul 2026
First PostedJul 19, 2017
Enrollment StartFeb 17, 2014
Primary CompletionNov 18, 2015
Study CompletionOct 9, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.0 years ago
Interventions
TAVRdevice
Implantation of the SAPIEN 3