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EDWARDS INTUITY Elite Valve System

NCT02907463 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2019-11-22

Study results available
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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.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Christopher Young, MD FRCS · St. Thomas' Hospital

  • Gunther Laufer, Prof. Dr. med · AKH Vienna Dep. of Cardiovascular Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-04-30
Completion
2017-12-31

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02907463 on ClinicalTrials.gov