At a glance
ClinicalIndex Comparison RecordN/ACompleted· 295 enrolled
Drug / intervention
Aortic Valve Replacement with EDWARDS INTUITY Valve Systemdevice
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.
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
In Brief
A clinical study evaluating Aortic Valve Replacement with EDWARDS INTUITY Valve System for Aortic Valve Stenosis With Insufficiency and Aortic Valve Stenosis. Completed, enrolled 295 participants across 6 sites in 2 countries.
Detailed Summary
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedOct 2011
Primary CompletionDec 2017
TodayJul 2026
First PostedOct 3, 2011
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 14.7 years ago
Interventions
Aortic Valve Replacement with EDWARDS INTUITY Valve Systemdevice
Aortic Valve bioprosthesis