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

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES, FUWAI HOSPITAL · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients who have both a patent foramen ovale (PFO), which is a small hole in the heart, and migraines. The study will compare two types of devices used to close the PFO: a new biodegradable occluder that breaks down over time and a traditional metal occluder. Researchers want to see which device better helps reduce the frequency and severity of migraines in patients who have not found relief from other migraine medications.

To participate in this trial, individuals must be between 18 and 65 years old and have a history of migraines that disrupt their daily lives. They should also have a diagnosed PFO and have tried at least three different migraine prevention medications without significant improvement. Participants will be randomly assigned to receive either the biodegradable or metal occluder and will be monitored for their symptoms over time. This study is an exciting opportunity to find out if the new biodegradable option can provide better relief from migraines without the long-term complications sometimes associated with metal devices.

Gender

ALL

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