EDWARDS INTUITY Valve System CADENCE-MIS Study

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 31, 2015

Study Completion Date

August 31, 2015

Conditions
Aortic Valve DiseaseAortic Stenosis
Interventions
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

Trial Locations (1)

04289

Leipzig Heart Center, Leipzig

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY