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COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

Non Recruiting
18-65 years
All
Phase 4

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Overview

Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.

Eligibility

Inclusion Criteria:

  1. Age 18-65 ;
  2. Diagnosed migraine by ICHD-3
  3. History of migraine longer than 1 year
  4. TCD/TTE/TEE diagnosed patent foramen ovale
  5. Willing to participant and agree to follow-ups
  6. Undertook medication therapy for three months without a responder rate higher or equal to 50%

Exclusion Criteria:

  1. Migraine caused by other reason
  2. Had TIA/stroke history
  3. Hypersensitive or hyposensitive to the study drug

Study details
    Migraine
    Patent Foramen Ovale

NCT05561660

Chinese Academy of Medical Sciences, Fuwai Hospital

21 October 2025

FAQs

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