Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.

Inclusion Criteria:

• Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders
• Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO，of which the degree is moderate to large RLS
• Subjects who have not responded to or cannot take common migraine preventive medications
• Willing to participate in follow-up visits

Additional Inclusion Criteria:

• Transcatheter closure group: Closure of PFO is performed
• Contrast group: Subjects who meet the Inclusion Criteria, but refuse to undergo closure procedure

Exclusion Criteria:

• Seizure disorder
• Other organic central nervous system disease
• Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury
• Evidence of alcohol, drug or substance abuse within the previous year

Additional Exclusion Criteria for Transcatheter closure group:

• Subjects with intracardiac thrombus or tumor
• Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
• Subjects with left ventricular aneurysm or akinesis
• Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
• Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
• Subjects with contraindication to aspirin or Clopidogrel therapy
• Pregnant or desire to become pregnant within the next year