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EDWARDS INTUITY Valve System CADENCE Study — CADENCE  

Aortic Stenosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02688153
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date April 2016
View Details
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