Septal closure of patent foramen ovale: does it prevent migraine?
- Conditions
- Migraine, foramen ovale persistens, closureNervous System DiseasesEpisodic and paroxysmal disorders
- Registration Number
- ISRCTN54702843
- Lead Sponsor
- St Jude Medical Inc (Belgium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Migraine with aura
2. Migraine history of at least one year:
a. at least two migraine attacks/month
b. at least one migraine attack with aura
3. Failure or intolerance to two classes prophylactic migraine medication
4. Aged 18 to 50 years
5. Right to left shunt suitable for closure
1. History of 15 or more headache days per month
2. Taking preventive medication for other conditions other than migraine
3. Eight or more non-migraine headache days/month
4. Overuse of acute headache medication (use on ten or more days/month)
5. Severe central nervous system disease
6. Previous surgical or device closure of Patent Foramen Ovale (PFO)/Atrial Septal Defect (ASD)
7. Atrial heart valve
8. Pacemaker or Implantable Cardioverter Defibrillator (ICD) implanted within past three months
9. History of atrial fibrillation
10. Undergoing dialysis
11. New York Heart Association (NYHA) class three or four cardiac failure
12. Pregnant
13. Anticoagulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Number of patients experiencing 50% reduction of migraine in closure group compared with sham group.<br><br> Outcomes will be measured monthly from three to nine months after closure.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Mean values of monthly migraine periods<br> 2. Quality of Life (QoL) using headache impact test questionaire<br><br> Outcomes will be measured monthly from three to nine months after closure.<br>