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This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00355056
First received: July 19, 2006
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Migraine Headaches
Patent Foramen Ovale
Other: Sham Procedure
Device: AMPLATZER PFO Occluder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 230
Study Start Date: January 2006
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355056

  Show 30 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
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
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00355056     History of Changes
Other Study ID Numbers: AGA-010, G050054
Study First Received: July 19, 2006
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
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

ClinicalTrials.gov processed this record on October 19, 2014