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Engager Direct Aortic Clinical Study

NCT01789567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-07-26

Study results available
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Summary

To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Engager™ aortic valve

Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Hendrik Treede, MD · University Hospital Halle, Germany

  • David Holzhey, MD · Leipzig Heart Institute, Germany

  • Sabine Bleiziffer, MD · German Heart Center Munich, Germany

  • Marian Branny, MD · Nemocnice Podlesi, Trinec, Czech Republic

  • Neil Moat, MD · Royal Brompton Hospital, London, United Kingdom

  • Vinayak Bapat, MD · St. Thomas' Hospital, London, United Kingdom

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-07-31
Completion
2015-06-30

Countries

  • Czechia
  • Germany
  • 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 NCT01789567 on ClinicalTrials.gov