NCT01789567

Engager Direct Aortic Clinical Study

Engager Direct Aortic Clinical Study: Medtronic Engager™ Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach in patients with symptomatic severe aortic valve stenosis at high or extreme risk for surgical aortic valve replacement for which treatment via direct aortic access is preferred.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Engager™ aortic valve	Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-07-01
• Completion: 2015-06-01
• First posted: 2013-02-12
• Last updated: 2018-07-26
• Results posted: 2018-07-26

Locations

6 sites across 3 countries: Czechia, Germany, United Kingdom