The heart defect being studied is known as Patent Foramen Ovale (PFO), a structural defect where a small hole between the right and left atria (upper chambers of the heart) fails to close in infancy. An estimated 25% of the adult population has a PFO but in most people it is usually considered benign.
The objective of the trial is to determine if patients who undergo a PFO closure procedure have a decreased number of migraines over a one year follow-up period as compared to those who are maintained only on drug therapy. Enrollment in the study is expected to begin by the end of 2005.
“We are very pleased to receive conditional approval to begin this important effort to study the effects of PFO closure on migraine sufferers,” said Paul Buckman, president of St Jude Medical’s Cardiology Division. “Recurrent migraines are very difficult for physicians to manage and are debilitating for many patients. We believe that this study could provide important clinical insights into their future treatment.”
While there is currently only anecdotal proof of a cause-effect relationship between migraine and PFO, several clinical experiences have confirmed a strong association between the presence of PFO and migraines. Analysis by several physicians have shown that closure of PFO in patients with migraine and a previous stroke has been associated with a reduction in both intensity and frequency of migraine attacks.