Clinical Trial: PRIMA PFO Migraine Trial

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)

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 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.
Sponsor: St. Jude Medical

Current Primary Outcome: Migraine headache frequency [ Time Frame: 12 months ]

Original Primary Outcome: Migraine headache frequency

Current Secondary Outcome: Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure [ Time Frame: 12 months ]

Original Secondary Outcome: Responder rate; Acute migraine medication use; Quality of life evaluations; Adverse events

Information By: St. Jude Medical

Dates:
Date Received: July 20, 2007
Date Started: May 2006
Date Completion:
Last Updated: April 6, 2015
Last Verified: April 2015