Patent Foramen Ovale Closure with the GORE® CARDIOFORM Septal Occluder for Migraine Headache Relief: The Prospective, Randomized, Placebo-, Sham-Controlled RELIEF Study (Preprint)

Abstract

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.

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).

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).

Outcomes will be reported following study completion.

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.

The study is registered with ClinicalTrials.gov (NCT04100135).