Premium Trial - United States
AMPLATZER® PFO Occluder - Notice of Availability - Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.
THE HEART AND MIGRAINE CONNECTION
Patent Foramen Ovale is a defect in the atrial septum, the wall between the two upper chambers of the heart. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent Foramen Ovale (PFO) results.
Retrospective research has shown that a significant number of people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency, and severity of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought. The Premium Trial is designed to evaluate the effectiveness of PFO closure as a treatment for migraine. The trial is a prospective, randomized, sham-controlled, double blind, multi-center study to evaluate safety and efficacy.
To participate, patients must be 18-55 years of age with migraine (with or without aura) reported to have a 3 month history of 6-14 headache days per month and confirmed presence of a PFO. Participants will either have closure of the PFO with the AMPLATZER® PFO Occluder and standard of care medical treatment, or standard of care medical treatment only.
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