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Enable® Aortic Sutureless Bioprosthesis Evaluation

NCT01720342 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2019-05-01

No results posted yet for this study

Summary

The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency

Interventions

PROCEDURE

Aortic Valve Replacement surgery

Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Otto Dapunt, MD · LKH Universitätsklinik Graz, Austria

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • 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 NCT01720342 on ClinicalTrials.gov