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This study is currently recruiting participants.
Verified February 2013 by AGA Medical Corporation
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00355056
First received: July 19, 2006
Last updated: February 6, 2013
Last verified: February 2013
History of Changes

July 19, 2006
February 6, 2013
January 2006
March 2014   (final data collection date for primary outcome measure)
Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks.
Complete list of historical versions of study NCT00355056 on ClinicalTrials.gov Archive Site
Change in the average number of migraine days; change in MIDAS score; reduction in the number of acute and/or rescue migraine medications; complete closure of the defect; improvement of Quality of Life; Improvement in the BECK Depression Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in the average number of migraine days; change in MIDAS score; reduction in the number of acute and/or rescue migraine medications; complete closure of the defect; improvement of Quality of Life; Improvement in the BECK Depression Inventory
Not Provided
Not Provided
 
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Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.

The Purpose of this study is to evaluate 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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Migraine Headaches
  • Patent Foramen Ovale
  • Other: Sham Procedure
    Sham Procedure
  • Device: AMPLATZER PFO Occluder
    Patients in this arm will receive the AMPLATZER PFO Occluder device
  • Sham Comparator: 1
    Intervention: Other: Sham Procedure
  • Experimental: 2
    PFO device Closure
    Intervention: Device: AMPLATZER PFO Occluder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact: Maren Wagner mwagner2@sjm.com
United States
 
NCT00355056
AGA-010, G050054
Yes
AGA Medical Corporation
AGA Medical Corporation
Not Provided
Principal Investigator: Sherman Sorensen, M.D. Intermountain Medical Center
Principal Investigator: Stephen Silberstein, M.D. Thomas Jefferson University
Principal Investigator: Jonathan Tobis, M.D. University of California, Los Angeles
AGA Medical Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP