Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Yi Yang1 site in 1 country258 target enrollmentJanuary 2013

ConditionsForamen Ovale, Patent Migraine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Foramen Ovale, Patent
Sponsor: Yi Yang
Enrollment: 258
Locations: 1
Primary Endpoint: Contrast-enhanced Transcranial Doppler
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

January 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yi Yang

Responsible Party

Sponsor Investigator

Principal Investigator

Yi Yang

Associated Dean of First Hospital of Jilin University

The First Hospital of Jilin University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Contrast-enhanced Transcranial Doppler

Time Frame: 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.