Heart fix may stop migraines: new trial tests Hole-Closing procedure
NCT ID NCT07170176
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether closing a small hole in the heart (called a PFO) can reduce migraine attacks and improve brain function. Researchers will compare 150 adults with migraines and a PFO who get the closure procedure to those who don't. The goal is to see if the procedure cuts monthly migraine days and eases pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Percutaneous patent foramen ovale closure device
- What this could lead to
- If it works, this could point toward a non-drug treatment for migraines in people with a common heart defect.
- What could go wrong
- This is a small, early-stage study with no control group for the procedure, so results may not be conclusive. The procedure itself carries risks like bleeding or device complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults aged 18 to 60 years. 2. Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt. 3. For the case group: Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-3). 4. For the control group: No history of migraine. 5. Willing and able to provide written informed consent. 6. Education level of primary school or higher. Exclusion Criteria: 1. Patients with a history of PFO closure or other migraine-related surgical treatments; 2. Patients with other severe cardiac or neurological diseases, mental disorders, or psychological conditions; 3. Patients with contraindications to closure surgery or MRI scans (e.g., severe infection, coagulation dysfunction, cardiac pacemakers, aneurysm clips, metallic foreign bodies in the eye, non-removable metal dentures, etc.); 4. Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Luoyang Central Hospital
RECRUITINGLuoyang, Henan, 471009, China
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The Second Hospital of Tianjin Medical University
RECRUITINGTianjin, Tianjin Municipality, 300211, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Migraines and tension headaches may be hidden companions to multiple sclerosis
- Can tai chi ward off migraines? study pits ancient practice against modern medicine
- Can a common heart drug stop rhythm problems after a Stroke-Related heart repair?
- Hands-On spine therapy may offer new hope for migraine sufferers
- Can a targeted botox shot quiet the Brain's pain center for chronic migraine?