Trial Information

Summary: Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks.

Percutaneous 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 experienced their first migraine attack prior to age 50
• Subjects who have not responded to, or cannot take common migraine preventive 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 information: www.primatrial.com

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Trial listings updated: February 25, 2008 at 3:15:05 PM