Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
Conditions
Keywords
Migraine, Migraine with aura, Patent foramen ovale, PFO
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.
Interventions
DEVICEAMPLATZER® PFO Occluder Device
PFO device closure
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migraine headache frequency | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure | 12 months |
Countries
Canada, Germany, Switzerland, United Kingdom
Outcome results
None listed