NCT01015612

CoreValve® System Australia/New Zealand Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 634 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk

Detailed description

Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve® System	The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-10-01
• Completion: 2016-09-01
• First posted: 2009-11-18
• Last updated: 2019-11-12
• Results posted: 2018-10-19

Locations

10 sites across 2 countries: Australia, New Zealand