Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02127294|
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : January 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Foramen Ovale, Patent Migraine||Device: transcatheter patent foreman ovale closure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||January 2016|
Experimental: Transcatheter closure group
Migraine patients with patent foreman ovale (PFO)，who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group.
Device: transcatheter patent foreman ovale closure
No Intervention: Contrast group
Migraine patients with PFO，who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127294
|First Hospital of Jilin University|
|Changchun, Jilin, China, 130000|
|Study Chair:||Yi Yang, MD, PhD||First Hospital of Jilin University|
|Study Director:||Yingqi Xing, MD, PhD||First Hospital of Jilin University|
|Principal Investigator:||Yuzhu Guo||First Hospital of Jilin University|