At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
EDWARDS INTUITY Valve System, Model 8300A +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 Using Minimally InvaSive Techniques
In Brief
A clinical study evaluating EDWARDS INTUITY Valve System, Model 8300A and Stented Aortic Bioprostheses for Aortic Valve Disease and Aortic Stenosis. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Disease, Aortic Stenosis
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
Primary CompletionMar 2015
Study CompletionAug 2015
First PostedFeb 2016
TodayJul 2026
First PostedFeb 3, 2016
Enrollment StartMay 1, 2012
Primary CompletionMar 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.4 years ago
Interventions
EDWARDS INTUITY Valve System, Model 8300Adevice
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.
Stented Aortic Bioprosthesesdevice
In comparison to control valves available on the market undergoing FS-AVR