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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06033937
Other study ID # 2022-1758-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2025

Study information

Verified date September 2023
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Xiangbin Pan, MD
Phone 88396666
Email panxiangbin@fuwaihospital.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 242
Est. completion date December 1, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age 18-65 ; 2. Diagnosed migraine by ICHD-3 3. History of migraine longer than 1 year, and symptoms severely disturbing daily life. 4. TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt 5. Willing to participant and agree to follow-ups 6. Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%. Exclusion Criteria: 1. Migraine caused by other reason 2. Had TIA/stroke history 3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs. 4. With contraindication to PFO occlusion

Study Design


Intervention

Device:
PFO occlusion
Patients in PFO occlusion group received PFO closure using devices.

Locations

Country Name City State
China Fuwai Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Responder rate Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase. From baseline period to 12-month treatment period
Secondary Migraine days change per month Change in the mean number of migraine days from baseline to treatment phase. From baseline period to 12-month treatment period
Secondary Number of migraine attacks change per month Change in the mean number of migraine attacks from baseline to treatment phase. From baseline period to 12-month treatment period
Secondary Percentage of complete migraine cessation Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase. From baseline period to 12-month treatment period
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