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The Prima Trial
This study evaluates 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 catheter laboratory setting. The trial will measure and compare headache frequency and severity from those who receive PFO closure to those who do not. Approximately 144 patients will be enrolled in the PRIMA Trial at approximately 15 sites in the EU and Canada.
The Heart and Migraine Connection
Patent Foramen Ovale is a defect in the atrial septum, the wall between the two upper chambers of the heart. The foramen ovale is a flap or tunnel-shaped hole in the atrial septum during foetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby's heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent Foramen Ovale (PFO) results.
A PFO occurs in about 1/4 of the population and can allow blood clots to move through blood vessels in the body. It is thought that small blood clots (micro embolisms) may trigger migraine attacks. Retrospective research has shown that some people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency and severity of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought.
Volunteer Criteria
The Prima Trial is a prospective, randomised, multi-centre, global clinical study designed to evaluate the possible connection between migraine headaches and PFO defects. Potential participants in the trial must meet a number of criteria to be considered for the trial, including:
- 18 to 65 years of age
- First migraine headache experienced prior to age 50
- Experienced migraine headaches with aura
- Unresponsive to two or more preventive headache medications.
Participants who meet all criteria for the trial will either have closure of the PFO with the AMPLATZER® PFO Occluder and standard of care medical treatment, or standard of care medical treatment only.
Migraine sufferers who may meet the criteria, and are interested in participating in the trial can get more information at www.primatrial.com or through their headache specialist.