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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 18-65 ;

• Diagnosed migraine by ICHD-3

• History of migraine longer than 1 year, and symptoms severely disturbing daily life.

• TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt

• Willing to participant and agree to follow-ups

• Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.

Locations
Other Locations
China
Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiangbin Pan, MD
panxiangbin@fuwaihospital.org
88396666
Backup
Fengwen Zhang, MD
zhangfengwen08@126.com
88396666
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 242
Treatments
Migraine Medication Group
PFO Occlusion Group
Sponsors
Leads: Chinese Academy of Medical Sciences, Fuwai Hospital

This content was sourced from clinicaltrials.gov