Patient Information
Help answer an important question about migraines
Medical evidence indicates that a common heart defect called
patent foramen ovale (PFO) could contribute to migraine headaches. A PFO is a small opening between the upper chambers of the heart that occurs in approximately 25 percent of the population.
1
In recent years, doctors have noted that many people who have had PFO closure for reasons other than migraines have reported a reduction in frequency or elimination of migraine attacks.
2
The PREMIUM Trial is designed to determine if closing a PFO reduces the frequency of migraine headaches. The trial is a randomized, double-blind study. This means participants will have a 50/50 chance of receiving PFO closure with AGA Medical's AMPLATZER
® PFO Occluder and standard-of-care medical treatment or standard-of-care treatment alone.
The procedure is minimally invasive and most patients leave the hospital within 24 hours.
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Learn more about PREMIUM TRIAL
Learn more about the importance of clinical trials
1 Hagen, PT et al, Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc. 1984; 59(1):17-20
2 Schwerzmann M, Wiher S, Nedeltchev K, et al. "Percutaneous closure
of patent foramen ovale reduces the frequency of migraine attacks."
Neurology 2004:62:1399-1401.