Trial Information

Summary: Percitaneous Closure of Patent Foramen Ovale in Migraine with Aura - A Randomized Prospective Study: PRIMA Migraine Clinical Trial

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO - slit like opening between the upper chambers of the heart), who are randomized to either device closure of the PFO using the AMPLATZER® PFO Occluder, or continue with standard medical management.

Eligibility:

Ages Eligible for Study: 18 Years - 65 years
Genders Eligible for Study: Both

Inclusion Criteria:

• Subjects between ages 18-65 years of age
• Subjects who experience migraine headaches with aura
• Subjects who experience their first migraine attack prior to age 50
• Subjects who have not responded to, or cannot take common migraine preventative medications

Exclusion Criteria:

• Subjects with clinical history of stroke
• Subjects who can not take aspirin or Clopidogrel (Plavix) therapy
• Subjects who are pregnant or desire to become pregnant within the next year

For further informations: agaprimanurse@threewire.com

If you would like to learn more about participating in this study, please send an e-mail message using the form below.