Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:32 AM
Study NCT ID:
NCT07421557
Status:
AVAILABLE
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access of Occlutech's Atrial Flow Regulator
Sponsor:
Occlutech International AB
Organization:
Study Overview
Official Title:
None
Status:
AVAILABLE
Status Verified Date:
2026-02
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:
None
Brief Summary:
Occlutech AFR use allowed per FDA's Expanded Access program.
Detailed Description:
Occlutech AFR use allowed per FDA's Expanded Access program. Each individual request is sent for FDA approval and the site's IRB approval per regulations.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: