Heart hole closure for migraines? tiny study halted early
NCT ID NCT04100135
First seen Jun 25, 2026 · Last updated Jun 25, 2026
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
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Columbia University Medical Center
New York, New York, 10032, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
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Medical Center of the Rockies
Loveland, Colorado, 80538, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Mercy One Iowa Heart Center
West Des Moines, Iowa, 50314, United States
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SJH Cardiology Associates
Liverpool, New York, 13088, United States
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Santa Barbara Cottage Hospital Research Institute
Santa Barbara, California, 93105, United States
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South Denver Cardiology
Denver, Colorado, 80120, United States
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UCLA Health
Los Angeles, California, 90095, United States
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University at Buffalo
Buffalo, New York, 14203, United States
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University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
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Yale University School of Medicine
New Haven, Connecticut, 06510, United States
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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.