NCT01348438

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

Completed NA Last updated 18 September 2018

What this trial tests

NA trial testing Medtronic Engager Transcatheter Aortic Valve Implantation System in Aortic Valve Stenosis in 125 participants. Completed in 25 January 2018.

Timeline

12 September 2011

Primary endpoint
28 February 2013

25 January 2018

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	125
Start date	12 September 2011
Primary completion	28 February 2013
Estimated completion	25 January 2018
Sites	9 locations across Belgium, Switzerland, Israel, Germany

Drugs / interventions tested

• Medtronic Engager Transcatheter Aortic Valve Implantation System

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intermediate follow-up results from the multicenter engager European pivotal trial.
   Holzhey D, Linke A, Treede H, Baldus S, et al · · 2013 · cited 26× · PMID 24021766 · DOI 10.1016/j.athoracsur.2013.06.089