Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
107 participants
INTERVENTIONAL
2006-05-31
2013-02-28
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
PREVENTION
NONE
Study Groups
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Medical Management
No interventions assigned to this group
PFO Closure
AMPLATZER® PFO Occluder Device
PFO device closure
Interventions
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AMPLATZER® PFO Occluder Device
PFO device closure
Eligibility Criteria
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Inclusion Criteria
* Subjects who have migraine headaches with aura diagnosed by a doctor
* Subjects who have not responded to or cannot take common migraine preventive medications
Exclusion Criteria
* Subjects who cannot take aspirin and clopidogrel (Plavix)
* Subjects who are 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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Prima Trial Steering Committee
Role: STUDY_CHAIR
Locations
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University of Calgary- Foothills Hospital
Calgary, Alberta, Canada
Alberta Health Services and the University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
University of Ottawa
Ottawa, Ontario, Canada
Davisville Medical Center
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada
Unfallkrankenhaus Berlin
Berlin, , Germany
Martin-Luther-University Halle-Wittenberg
Halle, , Germany
Universitätsklinikum Hamburg
Hamburg, , Germany
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
Kiel, , Germany
Universitätsklinikum Münster
Münster, , Germany
Swiss Cardiovascular Center Bern
Bern, , Switzerland
Kopfwehzentrum Hirslanden Zürich
Zurich, , Switzerland
Royal Sussex County Hospital
Brighton, , United Kingdom
St. Mary's Hospital Imperial College Healthcare NHS Trust
London, , United Kingdom
South Manchester University Hospital
Manchester, , United Kingdom
Countries
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References
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Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, Malik I, Ray S, Zermansky A, Findling O, Windecker S, Meier B. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016 Jul 7;37(26):2029-36. doi: 10.1093/eurheartj/ehw027. Epub 2016 Feb 22.
Other Identifiers
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AGA010E
Identifier Type: -
Identifier Source: org_study_id
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