Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01605851
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2012-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GORE® Septal Occluder European Union Clinical Evaluation
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
GORE® Septal Occluder EU Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of Patent Foramen Ovale (PFO)
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).
Detailed Description:
None
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?: