Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM)

Yi Yang

Status: Completed

Conditions: Foramen Ovale, Patent; Migraine

Treatments: Device: transcatheter patent foreman ovale closure

Study type: Interventional

Funder types: Other

Identifiers

NCT02127294

PFO-1shsf

Details and patient eligibility

About

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

Enrollment: 258 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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258 participants in 2 patient groups

Transcatheter closure group

Experimental group

Description:

Migraine patients with patent foreman ovale (PFO)，who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group.

Treatment:

Device: transcatheter patent foreman ovale closure

Contrast group

No Intervention group

Description:

Migraine patients with PFO，who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group.