Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
2800
Trial Sponsor
Clinical Trial Start Date
2016
0Primary Completion Date
2017
0Study Completion Date
2017
0Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Other0
Observational Study Perspective
Other0
Participating Facility
Official Name
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 Registry0
Last Updated
November 22, 2019
0Study 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.
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