Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02127294

Acronym

EASTFORM

Enrollment

258

Registered

2014-04-30

Start date

2013-01-31

Completion date

2016-01-31

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foramen Ovale, Patent, Migraine

Keywords

Foramen Ovale, Patent, migraine, transcatheter patent foramen ovale closure, contrast-enhanced transcranial Doppler, Transthoracic Echocardiography

Brief summary

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

Interventions

DEVICEtranscatheter patent foreman ovale closure

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026