Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Not Applicable

Completed

• Conditions: Foramen Ovale, Patent; Migraine

• 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

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