PRIMA PFO Migraine Trial

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

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.

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.

Inclusion Criteria:

• Subjects who are age 18 to 65
• Subjects who have migraine headaches with aura diagnosed by a doctor
• Subjects who have not responded to or cannot take common migraine preventive medications

Exclusion Criteria:

• Subjects with a clinical history of stroke
• Subjects who cannot take aspirin and clopidogrel (Plavix)
• Subjects who are pregnant or desire to become pregnant within the next year