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The Gore RELIEF Clinical Study for People with Patent Foramen Ovale (PFO)
Protocol: SITE00000036
Full Title
GORE CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale for relief of migraine headaches
The University at Buffalo (UB) Department of Medicine is recruiting people who have patent foramen ovale (PFO) and experience migraines for a clinical trial. People with PFO have a hole in their heart. The goal of the study is to see if a new device (the GORE CARDIOFORM Septal Occluder) can help to treat migraines in people with PFO. It is also investigating the safety of the study device.

Participants will be enrolled in the study for about 2 years. They will be randomly assigned (which happens by chance, like flipping a coin) twice during the study. First, they will be randomly assigned to either receive migraine medication or a placebo (a look-alike pill that does not contain any medication). Those that receive the study medication will be randomly assigned to either receive the study device or to have a fake device implanted. They will complete several study visits and surveys.
Compensation: No
Adults 18 years or older Have been diagnosed with patent foramen ovale (PFO) Experience migraine headaches
Age Group: Adults
Principal Investigator: DAVID ZLOTNICK Open Study
Eleftheria Steinig
+1 716-888-4859
Want to Learn More?

Let us know how the study team can reach you. If you do not hear back within 2 business days, then reach out to the study team directly at the contact information above and someone will assist you.

Your information will be shared only with the research study team and administrative staff for recruitment and will remain confidential. Your information will be stored until study recruitment is closed. Should you no longer want this information to be provided in the aforementioned ways, please contact the study team directly.

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