Status:

RECRUITING

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Lead Sponsor:

Chinese Academy of Medical Sciences, Fuwai Hospital

Conditions:

PFO - Patent Foramen Ovale

Migraine

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. ...

Eligibility Criteria

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

Key Trial Info

Start Date :

March 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT06203873

Start Date

March 1 2024

End Date

March 1 2026

Last Update

December 4 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Fuwai Hospital

Beijing, Beijing Municipality, China, 100037

2

Fuwai Hospital

Beijing, Beijing Municipality, China, 100037