Common Patient Questions
Do I qualify for the PREMIUM study?
Participants must be:
- 18 to 65 years of age.
- Diagnosed with having migraine headaches.
- Unresponsive to at least two commonly accepted preventive-medication regimens.
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.
How do I enroll in the study?
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.
How is the PREMIUM Trial conducted?
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 (pain-relieving and preventive medications), or standard-of-care treatment only.
What happens during the procedure?
The procedure is minimally invasive. A doctor implants the AMPLATZER PFO Occluder using a catheter - a sterile, flexible, hollow tube - that is inserted in the patient's groin and navigated through large veins or arteries to the heart. The device consists of two wire-mesh discs, filled with polyester fabric, that closes the PFO. The procedure lasts about one hour. Most patients leave the hospital within 24 hours.
Do I have to pay for anything or will my insurance be billed?
The study sponsor will cover all costs of the study. However, you or your third party payer must provide payment for any non-study related tests or assessments. You should not incur any additional expenses for participating in this clinical study.
How many patients will be enrolled?
Approximately 230 patients will be enrolled in the PREMIUM Trial at up to 45 clinical trial sites around the United States.