Clinical trial NCT00505570: PRIMA PFO Migraine Trial
Official title: Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Migraine
Migraine With Aura
Patent Foramen Ovale
PFO
Keywords: Migraine
Migraine with aura
Patent foramen ovale
PFO
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-07-23
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Detailed description: The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Eligibility criteria: Inclusion Criteria:

* Subjects who are age 18 to 65
* 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 with a clinical history of stroke
* Subjects who cannot take aspirin and clopidogrel (Plavix)
* Subjects who are pregnant or desire to become pregnant within the next year

Primary outcomes:
measure: Migraine headache frequency
timeFrame: 12 months
Secondary outcomes:
measure: Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary- Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Health Services and the University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Davisville Medical Center
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Halle
country: Germany
facility: Martin-Luther-University Halle-Wittenberg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Kiel
country: Germany
facility: Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Bern
country: Switzerland
facility: Swiss Cardiovascular Center Bern
city: Zürich
country: Switzerland
facility: Kopfwehzentrum Hirslanden Zürich
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: South Manchester University Hospital
Study officials:
name: Prima Trial Steering Committee
role: STUDY_CHAIR
References:
citation: 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.