Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284837
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-12-08
Brief Title:
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation
Sponsor:
The Alfred
Organization:
The Alfred
Study Overview
Official Title:
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation
Status:
RECRUITING
Status Verified Date:
2024-02
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:
SAFER-TAVI
Brief Summary:
Transcatheter aortic valve implantation TAVI is a well known safe treatment for severe aortic stenosis To perform TAVI safely there is a need for two vascular entry access sites the primary and secondary access sites While the femoral approach remains the most common site for primary access secondary access which is needed for guidance during the procedure has drawn little attention in trials of TAVI The two secondary access sites most commonly used are the radial through an artery in the wrist and femoral through an artery in the groin access sites Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access but there are no randomized controlled data to confirm these findings Accordingly investigators aim to undertake a multicenter randomized controlled trial among patients who are undergoing transfemoral TAVI to assess if radial access is superior to femoral access as a secondary access site
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None