Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Not Applicable

Completed

• Conditions: Foramen Ovale, Patent; Migraine
• Interventions: Device: transcatheter patent foreman ovale closure

• Registration Number: NCT02127294
• Lead Sponsor: Yi Yang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-04-30
• Primary Completion: 2015-06
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcatheter closure group	transcatheter patent foreman ovale closure	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.

Primary Outcome Measures

Name	Time	Method
Contrast-enhanced Transcranial Doppler	within one year period	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.

Secondary Outcome Measures

Name	Time	Method
Headache Impact Test-6	within one year period, at least 3 months	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.

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China