Study Results
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View full resultsBasic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2006-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Medical Management
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure).
Sham Procedure
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.
PFO Closure
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device
Interventions
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Sham Procedure
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.
AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Sherman Sorensen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Stephen Silberstein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Jonathan Tobis, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Andrew Charles, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
UCLA School of Medicine
Los Angeles, California, United States
Memorial Hospital
Colorado Springs, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Medical Center of the Rockies
Fort Collins, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Cloud Hospital
Saint Cloud, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
St. Johns's Mercy Medical Center
St Louis, Missouri, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Children's Heart Center Las Vegas
Las Vegas, Nevada, United States
Mercy Hospital of Buffalo
Buffalo, New York, United States
University of Rochester Medical School
Rochester, New York, United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The Methodist Hospital
Houston, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
Inova Healthcare Services
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, Gurley JC. Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial. J Am Coll Cardiol. 2017 Dec 5;70(22):2766-2774. doi: 10.1016/j.jacc.2017.09.1105.
Other Identifiers
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AGA-010
Identifier Type: -
Identifier Source: org_study_id
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