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Updated: Feb 17, 2026

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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
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Migraine with aura and persistent foramen ovale.
1Royal Stoke University Hospital, Stoke-on-Trent, UK.
Eye (London, England)
|December 9, 2017
Summary
Persistent foramen ovale (PFO) closure may improve migraine with aura. The MIST trial investigated this, comparing PFO closure devices to a sham procedure, but faced design and execution challenges.
Area of Science:
- Neurology
- Cardiology
- Medical Devices
Background:
- The association between migraine with aura and right-to-left shunts, specifically persistent foramen ovale (PFO), is recognized.
- Observational studies suggest PFO closure may alleviate migraine with aura symptoms.
Purpose of the Study:
- To evaluate the efficacy of PFO closure in treating severe, intractable migraine with aura.
- To compare the STARFlex device for PFO closure against a sham procedure in a randomized controlled trial.
Main Methods:
- The Migraine Intervention with STARFlex Technology (MIST) Trial was a randomized, double-blind study.
- Participants had severe intractable migraine with aura and a moderate-to-large PFO.
- Intervention involved STARFlex device implantation for PFO closure versus a sham procedure.
Main Results:
- The study aimed to determine if PFO closure could cure migraine with aura.
- Discussion includes challenges encountered in the trial's design and execution.
Conclusions:
- The MIST trial's findings regarding PFO closure for migraine with aura require careful consideration due to design and execution issues.
- Further research may be needed to clarify the role of PFO closure in migraine management.
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