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EDWARDS INTUITY Valve System FOUNDATION Study

NCT02338154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 516

Last updated 2019-11-22

Study results available
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Summary

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis
  • Rapid Deployment Valves

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Dr. Glauber, MD · Organizational Affiliation: OSPEDALE "G. PASQUINUCCI" CREAS IFC-CNR

  • Prof.Christopher Young, MD FRCS · Guy's & St Thomas' Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • 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 NCT02338154 on ClinicalTrials.gov