NCT02672553

EDWARDS INTUITY Valve System CADENCE-MIS Study

A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve Replacement Using Minimally InvaSive Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (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 in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.

Detailed description

This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore \< 20 undergoing elective isolated aortic valve replacement (AVR) surgery. Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.

Conditions

• Aortic Valve Disease
• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	EDWARDS INTUITY Valve System, Model 8300A	To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.
DEVICE	Stented Aortic Bioprostheses	In comparison to control valves available on the market undergoing FS-AVR

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-03-01
• Completion: 2015-08-01
• First posted: 2016-02-03
• Last updated: 2019-01-28
• Results posted: 2019-01-28

Locations

1 site across 1 country: Germany