Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Migraine Clinical Trial

— EASTFORM  

Official title:

Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127294
• Other study ID #: PFO-1shsf
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: January 12, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Migraine
• Migraine Disorders

Intervention

Device:
• transcatheter patent foreman ovale closure

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

References & Publications (1)

Yang Y, Guo ZN, Wu J, Jin H, Wang X, Xu J, Feng J, Xing Y. Prevalence and extent of right-to-left shunt in migraine: a survey of 217 Chinese patients. Eur J Neurol. 2012 Oct;19(10):1367-72. doi: 10.1111/j.1468-1331.2012.03793.x. Epub 2012 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes