NCT01348438

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Medtronic Engager Transcatheter Aortic Valve Implantation System	Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System

Timeline

• Start date: 2011-09-12
• Primary completion: 2013-02-28
• Completion: 2018-01-25
• First posted: 2011-05-05
• Last updated: 2018-09-18

Locations

9 sites across 4 countries: Belgium, Germany, Israel, Switzerland