New Orleans-Based Ochsner Health System Seeking Patients for Headache, Heart Defect Study

By Anonymous

Ochsner Health System is seeking patients who suffer from severe migraine headaches and a common heart defect, Patent Foramen Ovale, for a study.

The study, called the Premium Trial, will evaluate whether a new PFO closure procedure reduces migraine headaches in patients.

The procedure, Amplatzer PFO Occluder, is a less-invasive alternative to open-heart surgery for closing a PFO, Ochsner said. The device is implanted via a catheter inserted in the patient’s groin.

More than 28 million people in the United States, or 13 percent of the population, suffer from migraine headaches, while about 20 percent experience an “aura” effect, a headache with pain accompanied by flashing light, vision loss and other temporary neurological changes, Ochsner said.

PFO, a small flap-like opening between the upper chambers of the heart, is found in about 25 percent of adults. The opening is normal in fetuses, but it usually closes shortly after birth.

When it stays open, or “patent,” it allows blood to bypass the filtering system of the lungs. Substances such as very small blood clots or chemicals in this unfiltered, non-regenerated blood traveling directly to the brain may trigger migraine attacks, scientists say.

Recent observational studies have reported that a significant number of patients experience a reduction in the frequency and severity of migraine headaches following closure of the PFO.

“The Premium Trial is important to help determine the relationship between PFO and migraine. If the results of the trial are positive, PFO closure may provide another important treatment option for this debilitating condition,” said Dr. Steve Jenkins, interventional cardiologist at Ochsner.

The Amplatzer PFO Occluder procedure typically takes less than an hour with the patient able to return home within 24 hours, Ochsner said.

AGA Medical, based in Golden Valley, Minn., is funding the studies. AGA’s Amplatzer Atrial Septal Occluder device is approved by the U.S. Food and Drug Administration.

(Copyright 2007 Dolan Media Newswires)

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