At a glance
ClinicalIndex Comparison RecordN/ACompleted· 583 enrolled
Drug / intervention
TAVR Implantation of the THV Prosthesisdevice
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 High Risk and Inoperable Patients
In Brief
A clinical study evaluating TAVR Implantation of the THV Prosthesis for Symptomatic Severe Aortic Stenosis. Completed, enrolled 583 participants across 40 sites in 2 countries.
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, severe aortic stenosis, and are in high risk.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Severe Aortic Stenosis
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
Primary CompletionSep 2015
First PostedJul 2017
Study CompletionAug 2020
TodayJul 2026
First PostedJul 19, 2017
Enrollment StartOct 1, 2013
Primary CompletionSep 1, 2015
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.0 years ago
Interventions
TAVR Implantation of the THV Prosthesisdevice
Patients with TAVR implantation