COMPETE Cohort Study
NCT06033937 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 242
Last updated 2023-09-13
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
- DEVICE
-
PFO occlusion
Patients in PFO occlusion group received PFO closure using devices.
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences, Fuwai Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-01
- Primary Completion
- 2024-01-01
- Completion
- 2025-12-01
- FDA Device
- Yes
Countries
- China
Study Locations
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