COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
Status:
Not yet recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital