EDWARDS INTUITY Valve System CADENCE Study
EDWARDS INTUITY Valve System CADENCE Study
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.
This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass
 time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented
 aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical
 aortic valve replacement surgery with concomitant coronary bypass grafts.

 Additionally, the aim is to gather sufficient data to quantify the effect size of short term
 patient benefit outcomes previously identified from literature and finally to explore
 additional healthcare resource utilization or health economic endpoints.
Inclusion:

 -  ≥18 years of age

 -  aortic stenosis / mixed aortic stenosis and aortic insufficiency

 -  SAVR+CABG (1-4 distal anastomoses)

 -  Log. EuroSCORE ≥6

 -  NYHA Class ≥II

 Exclusion (i.a.):

 -  pure aortic insufficiency

 -  pre-existing prosthetic heart valve or ring

 -  congenital true bicuspid / unicuspid aortic valve

 -  LVEF <20%