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EDWARDS INTUITY Elite Valve System

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Contents

clinicaltrials.gov/study/NCT02907463
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT029074630
Health Conditions in Trial
Aortic stenosis
Aortic stenosis
0
Trial Recruitment Size
2800
Trial Sponsor
Edwards Lifesciences
Edwards Lifesciences
0
Clinical Trial Start Date
2016
0
Primary Completion Date
2017
0
Study Completion Date
2017
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Other0
Observational Study Perspective
Other0
Participating Facility
Medizinische Hochschule Hannover
Medizinische Hochschule Hannover
0
St Thomas' Hospital
St Thomas' Hospital
0
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
0
Study 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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