Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05409378
Status:
WITHDRAWN
Last Update Posted:
2023-05-31
First Post:
2022-05-24
Brief Title:
HLT Meridian TAVR Valve System Early Feasibility Study for Aortic Regurgitation
Sponsor:
HLT Inc
Organization:
HLT Inc
Study Overview
Official Title:
HLT Meridian TAVR Valve System Early Feasibility Study for Aortic Regurgitation
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
HLT Business Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIVAL - AR EFS
Brief Summary:
To evaluate the safety and performance of The Meridian TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None