EDWARDS INTUITY Valve System CADENCE Study

A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment

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%