Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505570
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2007-07-20
Brief Title:
PRIMA PFO Migraine Trial
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study Prima Trial
Status:
TERMINATED
Status Verified Date:
2019-02
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:
PRIMA
Brief Summary:
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale PFO a slit-like opening between the right and left upper chambers atria of the heart which normally closes at or soon after birth who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management
Detailed Description:
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale PFO a slit-like opening between the right and left upper chambers atria of the heart which normally closes at or soon after birth who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management
Study Oversight
Has Oversight DMC:
None
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?:
None