Heart hole closure for migraines? tiny study halted early

NCT ID NCT04100135

Terminated Symptom relief Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether closing a small hole in the heart (called a PFO) with a device could reduce migraine headaches. It planned to compare the real procedure to a sham (fake) procedure in adults aged 18-55 with frequent migraines. However, the study was stopped early after enrolling only 7 people, so no reliable conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: GORE® CARDIOFORM Septal Occluder (a device to close a hole in the heart) and antiplatelet drugs (clopidogrel or prasugrel)
What this could lead to: If it worked, closing a common heart hole might reduce migraine days for some people.
What could go wrong: The study was terminated early with only 7 participants, so we have very little data. The procedure also carries risks like bleeding or infection, and requires months of blood-thinning medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

migraine disorder migraine with aura patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MIGRAINE PATENT FORAMEN OVALE PFO - PATENT FORAMEN OVALE

Contacts and locations

Locations

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Columbia University Medical Center

New York, New York, 10032, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States
Medical Center of the Rockies

Loveland, Colorado, 80538, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Mercy One Iowa Heart Center

West Des Moines, Iowa, 50314, United States
SJH Cardiology Associates

Liverpool, New York, 13088, United States
Santa Barbara Cottage Hospital Research Institute

Santa Barbara, California, 93105, United States
South Denver Cardiology

Denver, Colorado, 80120, United States
UCLA Health

Los Angeles, California, 90095, United States
University at Buffalo

Buffalo, New York, 14203, United States
University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States
Yale University School of Medicine

New Haven, Connecticut, 06510, United States

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