Effectiveness and Safety of Transcathet… | Clinical Trial

Key information

Conditions

Foramen Ovale, Patent Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Headache Disorders Headache Disorders, Primary Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Migraine Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcatheter patent foreman ovale closure

Device

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.

Secondary outcomes

Headache Impact Test-6

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Acronym: EASTFORM

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Apr 30, 2014
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed