NCT01240902

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

Medtronic CoreValve® U.S. Pivotal Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,453 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
DEVICE	Surgical Aortic Valve Replacement (SAVR)	Surgical Aortic Valve Replacement (SAVR)

Timeline

• Start date: 2010-12-10
• Primary completion: 2014-08-01
• Completion: 2019-05-15
• First posted: 2010-11-15
• Last updated: 2022-10-25
• Results posted: 2015-06-08

Locations

45 sites across 1 country: United States