At a glance
ClinicalIndex Comparison RecordN/ACompleted· 120 enrolled
Drug / intervention
EDWARDS INTUITY +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.
A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
In Brief
A clinical study evaluating EDWARDS INTUITY and Stented aortic bioprostheses for Aortic Valve Disease and Aortic Stenosis. Completed, enrolled 120 participants across 1 site.
Detailed Summary
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Disease, Aortic Stenosis
CountriesFrance
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedFeb 2016
Primary CompletionApr 2016
TodayJul 2026
First PostedFeb 23, 2016
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.4 years ago
Interventions
EDWARDS INTUITYdevice
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG.
Stented aortic bioprosthesesdevice
In comparison to control valves available on the market.