At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessing Clinical Outcomes Using the EDWARDS INTUITY Elite Valve System in Isolated AVR Using Minimally InvaSive Surgery In a EurOpean Multi-ceNter, Active, Post-market Registry
In Brief
An observational study for Aortic Valve Disease and Aortic Stenosis. Completed, enrolled 280 participants across 23 sites in 9 countries.
Detailed Summary
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.