Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

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

Official Title
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Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Conditions
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Foramen Ovale, Patent, Migraine

Intervention / Treatment
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* Device: transcatheter patent foreman ovale closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter closure group<br>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. | Device: transcatheter patent foreman ovale closure<br> <br> |
| No Intervention: Contrast group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-enhanced Transcranial Doppler | Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively. | within one year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Impact Test-6 | All patients complete HIT-6 score at baseline. Patients in transcatheter closure group follow-up at 1 month, 3 month, 6 month and 1 year after closure, respectively. Patients in contrast group follow-up twice during one year period. | within one year period, at least 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foramen Ovale, Patent, migraine, transcatheter patent foramen ovale closure, contrast-enhanced transcranial Doppler, Transthoracic Echocardiography