Currently Enrolling Study

Migraine Headaches and PFO

Some people have a small hole between the chambers of the heart called a patent foramen ovale (PFO).  People with PFOs may not have any symptoms and may not even know they have a PFO.

Researchers are studying whether PFOs might have an effect on migraine headaches. If you have severe migraine headaches that haven’t responded to other treatments, you may be eligible for the PREMIUM study.

The purpose of the PREMIUM study is to see if closing a PFO with a device called a PFO occluder will lead to fewer migraine headaches.

Subjects must be between the ages of 18 and 55, and have both a PFOs and severe migraines. The migraines can be with or without auras. Several tests and procedures will be done to make sure potential subjects qualify for the study. All subjects who qualify will have a procedure called catheterization, which involves sedation and insertion of a needle through a vein in the groin area.  Half the subjects will be implanted with the device to close the PFO. You won’t know if you are getting the device or not. Subjects will take Aspirin for six months and Plavix for one month after the procedure.

During the first year, you will come back to the clinic most months for a checkup, and once a year thereafter until the end of the study. Your participation could last up to 5 years.

For more info, contact Sara Kivolowitz, MS at (608) 265-0633 or 1-800-755-5667. 

You can also email us at ctrials@clinicaltrials.wisc.edu.