Status:
COMPLETED
PREMIUM Migraine Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Migraine Headaches
Patent Foramen Ovale
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headac...
Detailed Description
The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.
Eligibility Criteria
Inclusion
- Subjects diagnosed as having migraine headaches both with and without aura
- Have a Patent Foramen Ovale (PFO)
- A migraine history and show a refractoriness to medical treatment
- Willing to participate in follow-up visits
Exclusion
- Subjects whose primary headaches are other than migraine headaches
- Who overuse migraine treatments
- With a clinical history of stroke or Transient Ischemic Attack (TIA)
- With contraindication to aspirin therapy and Clopidogrel
- Pregnant or desire to become pregnant within the next year
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00355056
Start Date
January 1 2006
End Date
December 1 2015
Last Update
July 30 2020
Active Locations (30)
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1
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
2
UCLA School of Medicine
Los Angeles, California, United States, 90095
3
Memorial Hospital
Colorado Springs, Colorado, United States, 80909
4
Swedish Medical Center
Englewood, Colorado, United States, 80113