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EDWARDS INTUITY Valve System CADENCE-MIS Study — CADENCE-MIS  

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 Using Minimally InvaSive Techniques

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02672553
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date May 2012
Completion date August 2015
View Details
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