IRB Number:

06-002890

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to compare the effects (good or bad)of the AMPLATZER PFO Occluder device in reducing further episodes of migraine in patients who have a PFO (an opening in the heart called a patent foramen ovale) with a large degree of abnormal blood flow from the right to the left chamber of the heart, to medical therapy.

Who is Eligible to Participate in the Study?

Patients who have a migraine diagnosis and a PFO would be eligible for consideration for the trial.

Minimum Age:

18

Maximum Age:

55

What is Involved With this Study?

There are multiple screening tests to establish the diagnosis of miagraine and presence of PFO. Some of the tests to be done are: transthoracic echocardiography, headache diary, electrocardiogram, prenancy test, blood tests, and questionnaires. After the screening criteria has been met, particpants would be put into one of two groups by chance, device group or medication group.

How long will the Study run?

The study is for 5 years.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Rebecca Fountain at (507) 255-4502.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 02/22/2007