Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-27 @ 8:26 AM
Study NCT ID:
NCT01876420
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
Sponsor:
Medtronic Cardiovascular
Organization:
Study Overview
Official Title:
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: