Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)

Status: Unknown
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

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

• TCD/TTE/TEE diagnosed patent foramen ovale

• Willing to participant and agree to follow-ups

• Undertook medication therapy for three months without a responder rate higher or equal to 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: 2022-10-01
Completion Date: 2025-10-01
Participants
Target number of participants: 460
Treatments
Experimental: PFO closure
Sham_comparator: Shame procedure
Sponsors
Leads: Chinese Academy of Medical Sciences, Fuwai Hospital

This content was sourced from clinicaltrials.gov