Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
1000
Trial Sponsor
Clinical Trial Start Date
2012
0Primary Completion Date
2015
0Study Completion Date
2015
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Intervention Name
Stented Aortic Bioprostheses0
EDWARDS INTUITY Valve System, Model 8300A0
Interventional Trial Phase
Not Applicable0
Official Name
A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve Replacement Using Minimally InvaSive Techniques0
Last Updated
January 28, 2019
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study 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.
Timeline
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Further Resources
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