NCT01876420

The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.

Detailed description

The study objectives are to assess the safety and clinical performance of the CoreValve™ Evolut R™ System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. These objectives will be accomplished by a prospective clinical study involving up to 60 implanted subjects among up to six study centers.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	The CoreValve™ Evolut R TAV™ system	CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-08-01
• Completion: 2016-10-01
• First posted: 2013-06-12
• Last updated: 2018-08-22
• Results posted: 2018-08-22

Locations

6 sites across 3 countries: Australia, New Zealand, United Kingdom