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ClinicalTrials.gov Identifier: NCT00355056
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Headaches Patent Foramen Ovale Other: Sham Procedure Device: AMPLATZER PFO Occluder Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.
Study Start Date : January 2006
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Sham Comparator: 1 Other: Sham Procedure
Sham Procedure

Experimental: 2
PFO device Closure
Device: AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device




Primary Outcome Measures :
  1. Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355056


  Show 30 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
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
Principal Investigator: Andrew Charles, MD University of California, Los Angeles

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00355056     History of Changes
Other Study ID Numbers: AGA-010
G050054
First Posted: July 21, 2006    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by St. Jude Medical:
Migraine
PFO
Migraine Headache
patent foramen ovale

Additional relevant MeSH terms:
Migraine Disorders
Headache
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities