Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-02-20 @ 1:31 PM
Study NCT ID:
NCT03309332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-13
First Post:
2017-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMPLATZER PFO Occluder Post Approval Study
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
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:
PFO PAS
Brief Summary:
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
Detailed Description:
A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: