NCT06033937

COMPETE Cohort Study

Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 242 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.

Conditions

• PFO - Patent Foramen Ovale
• Migraine

Interventions

Type	Name	Description
DEVICE	PFO occlusion	Patients in PFO occlusion group received PFO closure using devices.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-01-01
• Completion: 2025-12-01
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study