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Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial

NCT01348438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-09-18

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic Engager Transcatheter Aortic Valve Implantation System

Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Volkmar Falk, Prof. · University of Zurich

  • Jean-Louis Vanoverschelde, Prof. · Cliniques Universitaires Saint-Luc, Brussels

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-12
Primary Completion
2013-02-28
Completion
2018-01-25

Countries

  • Belgium
  • Germany
  • Israel
  • Switzerland

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 NCT01348438 on ClinicalTrials.gov