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Migraine with aura is more prevalent in individuals with a patent foramen ovale (PFO) than in the general population. Reports of resolved or improved migraine in retrospective studies of percutaneous-device closure of PFO for stroke provided the rationale for this prospective, randomized trial. The study was funded by the device manufacturer, which also had a substantial role in its design and oversight.
Included were 147 patients with ≥5 migraine headache days per month who had failed treatment with at least two classes of preventive medication and who had a moderate to large right-to-left shunt due to a PFO. They were randomized to percutaneous closure with implantation of a STARFlex septal repair device or to a sham procedure under genera…