Clinical Trial Fact Sheet / Eligibility

What is the PREMIUM Trial?
This clinical study will help determine whether a common heart defect, patent foramen ovale (PFO), contributes to migraine headaches. A PFO is a small opening between the upper chambers of the heart that occurs in about 25% of Americans.¹

The PREMIUM Trial is a randomized, double-blind study. This means participants will have a 50/50 chance of receiving PFO closure with AGA Medical's AMPLATZER® PFO Occluder and standard-of-care medical treatment or standard-of-care treatment only.

Working with neurologists, cardiologists and other physicians, AGA Medical LLC is recruiting migraine patients at up to 45 trial sites across the country. Approximately 230 patients will be enrolled. Find a physician near you.

The minimally invasive procedure lasts approximately one hour. Most patients leave the hospital within 24 hours.

How is the PREMIUM trial conducted?
Participants will be randomly assigned to one of two groups. One group will receive the AMPLATZER PFO Occluder and standard of care. The second group will not receive the device, and instead will follow the current standard of care as prescribed by a physician.

Study participants will receive all study-related procedures and care at no cost. Physicians will monitor both groups of patients during the study period. Results will be measured and compared between the groups.

Who can participate?
To qualify to participate in the PREMIUM Trial, participants must meet the following criteria:

• 18 to 65 years of age
• Diagnosed with having migraine headaches
• Unresponsive to at least two commonly accepted preventive-medication regime.

Even if you meet the above criteria, your health history and other factors will be considered to determine whether you could be a candidate for the trial. To see if you might qualify, answer a short list of questions or call 1-866-460-5603.

How do I enroll in the PREMIUM Trial?
Contact a participating physician. For a list of cardiologists and neurologists involved in the PREMIUM Trial, go to the physician locator.

Participants will be given further details on the study from the physician. Prior to enrollment, participants will receive an Informed Consent Document to review, which provides further details on the study treatment and what to expect.

¹Hagen, PT et al, Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc. 1984; 59(1):17-20