Trial Information

Summary: Prospective Randomized investigation to Evaluate incidence of headache reduction in subjects with Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management: PREMIUM Migraine Trial

This study evaluates the impact of percutaneous closure of a patent foramen ovale (a hole in the heart), using the AMPLATZER ® PFO Occluder, on the incidence of migraine headaches.

Eligibility:

Ages eligible for study: 18 years - 55 years
Genders eligible for study: Both

Inclusion Criteria:

• Subjects diagnosed as having migraine headaches both with and without aura
• Subjects who have a Patent Foramen Ovale (PFO)
• Subjects who have a migraine history and show a refractoriness to medical treatment
• Subjects willing to participate in follow-up visits

Exclusion Criteria:

• Subjects whose primary headaches are other than migraine headaches
• Subjects who overuse migraine treatments
• Subjects with a clinical history of stroke or Transient Ischemic Attack (TIA)
• Subjects with contraindication to aspirin therapy and Clopidogrel
• Pregnant or desire to become pregnant within the next year

For further information: www.premiumtrial.com

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: June 1, 2008 at 5:46:08 AM