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Patent Foramen Ovale (PFO) is a condition where a small hole exists between the right and left atria (upper chambers of the heart), allowing some blood flow from the right to left side of the heart. In the last several years, doctors have noted that a significant number of people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency, or elimination of migraine attacks.* For this reason, further knowledge on the relationship between PFO and migraine is being sought. The PREMIUM Trial is a clinical study designed to evaluate the effectiveness of PFO closure as a treatment for migraine. PFO closure is performed by placing an occlusion device into the PFO through a catheter in a catheterization laboratory. The trial is randomized, which means that participants will have a 50/50 chance of receiving PFO closure. Results will be measured and compared in both groups; those who receive PFO closure, and those who do not. Participants will not know if they have received PFO closure until the trial is completed. Approximately 466 patients will be enrolled in the Premium Trial at 35 clinical trial sites around the US. Sites are being added at this time. If you meet the pre-qualification requirements, you will be able to submit your name and contact information. You will then be notified when a site begins enrollment in your area. *References available upon request.
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DO I QUALIFY FOR THE PREMIUM TRIAL? There are a number of criteria that are required to be part of the trial, and a number of factors in your health history that might prevent you from being a participant. You can answer a short list of questions to see if you might qualify to participate in the Premium Trial.  |
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