Clinical Trial Fact Sheet

The Heart and Migraine Connection
Retrospective research has shown that a significant number of people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency, or cessation of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought.

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The AMPLATZER PFO Occluder closes the PFO to prevent blood from shunting to left side of the heart.

The PREMIUM Trial is designed to evaluate the safety and 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 setting. Approximately 230 patients will be enrolled in the PREMIUM Trial at up to 45 sites around the U.S.

Trial Design
The trial is a prospective, randomized, sham-controlled, double blind and multi-center study to evaluate safety and effectiveness.

Randomization Arms
Closure of the PFO with the AMPLATZER^® PFO Occluder and standard-of-care medical treatment, or standard of care medical treatment only.

Patient Population
Patients 18-65 years of age with migraine (with or without aura) reported to have approximately 6 to 14 headache days per month, failure/refractory/unresponsive to two previous commonly accepted medication treatments and demonstrated presence of PFO with significant shunt (greater than or equal to grade 4 with Transcranial Doppler).

Other inclusion and exclusion criteria must be met to qualify for the Trial. Contact AGA Medical or a Trial site for more information.

Baseline Testing (Included, but not limited to)
Initial testing for inclusion in the Trial includes: Medical history, two month headache diary, quality-of-life questionnaire, depression (BDI) and migraine disability assessment (MIDAS) survey, clinical neurological assessment, routine blood workup, EKG and Transcranial Doppler (TCD) evaluation for right to left shunt.

Follow-up
Patients will keep a headache diary and be evaluated by the investigating neurologist regularly for one year following randomization and annually there after.

End Points
Comparison of reduction in the number of reported headache attacks between the baseline phase and treatment phase in both groups.