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This study has been completed.

Sponsor:

Information provided by (Responsible Party):

St. Jude Medical

ClinicalTrials.gov Identifier:

NCT00355056

First received: July 19, 2006

Last updated: February 11, 2016

Last verified: February 2016

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

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

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 ]


Enrollment:	230
Study Start Date:	January 2006
Study Completion Date:	December 2015
Primary Completion Date:	February 2015 (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 (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

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

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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

More Information


Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00355056 History of Changes
Other Study ID Numbers:	AGA-010 G050054
Study First Received:	July 19, 2006
Last Updated:	February 11, 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

ClinicalTrials.gov processed this record on July 18, 2017

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