Previously submitted to: JMIR Research Protocols (no longer under consideration since Jul 24, 2024)
Date Submitted: Nov 30, 2023
Open Peer Review Period: Nov 29, 2023 - Feb 6, 2024
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Patent Foramen Ovale Closure with the GORE® CARDIOFORM Septal Occluder for Migraine Headache Relief: The Prospective, Randomized, Placebo-, Sham-Controlled RELIEF Study
ABSTRACT
Background:
The patent foramen ovale (PFO), a remnant of normal fetal circulation, has been associated with migraine. Sham-controlled clinical trials have yet to conclusively demonstrate that PFO closure reduces migraine attack frequency. Recent observational studies have suggested that a reduction in migraine headache frequency after treatment with P2Y12 platelet receptor inhibitors (thienopyridines) may be used to identify those in whom PFO plays a pathogenic role.
Objective:
This article details the background, rationale, design, and planned procedures for the multicenter, prospective, randomized, placebo- and sham-controlled GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF).
Methods:
The study will evaluate closure of the PFO for migraine headache relief in an enriched population comprised of patients pre-treated successfully with thienopyridines. Approximately 25 sites in the United States will randomize 150 patients (1:1), blinded, to receive either PFO closure or a sham procedure. The primary efficacy endpoint is comparison of reduction from baseline in the mean monthly migraine headache days between the PFO closure (N=75) and the sham procedure cohorts (N=75).
Results:
Outcomes will be reported following study completion.
Conclusions:
The inclusion criterion of successful pre-treatment with thienopyridine may allow for selection of patients with migraine in whom the PFO is playing a causal role in symptom expression and identify a PFO closure-responsive subgroup. Clinical Trial: The study is registered with ClinicalTrials.gov (NCT04100135).
Citation
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