NCT02688153

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Valve Disease
• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	EDWARDS INTUITY	To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG.
DEVICE	Stented aortic bioprostheses	In comparison to control valves available on the market.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-02-23
• Last updated: 2018-06-01
• Results posted: 2018-06-01

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study