WL Gore & Associates has announced that it is initiating the RELIEF clinical study—an investigational study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale (PFO) for the relief of migraine headaches utilising the Gore Cardioform septal occluder, a permanently implanted device.
“The Gore RELIEF clinical study will investigate whether PFO closure may reduce the number of monthly migraine headache days for select patients. No previous PFO closure migraine trial has yet included such clearly defined selection criteria designed to identify those patients expected to most likely respond to this potential, PFO-mediated mechanism,” said Robert Sommer (Columbia University Department of Medicine, New York, USA), national principal investigator, RELIEF clinical study. “Clinical experiences have suggested a platelet-based connection between migraine and PFO, and there may be a correlation between PFO closure responsiveness and thienopyridine responsiveness. PFO closure may offer a mechanical method to reduce or eliminate this trigger factor.”
The multicentre, prospective, randomised, placebo- and sham-controlled RELIEF study seeks a final enrolment of 150 patients responsive to the study drug, with documented PFO, ages 18 to 55, with a history of more than one migraine headache day per week.
The primary efficacy endpoint will be a reduction in the mean number of migraine headache days, comparing the reduction in the number of migraine headache days per month from baseline to follow-up. The primary safety endpoint is the proportion of subjects with any serious adverse event (SAE) related to the study device or study procedure through 30 days post procedure.
The Gore Cardioform septal occluder, combines unique materials and is designed to provide a soft and conformable option for PFO closure, currently indicated for secondary stroke prevention in select patients. The minimal, nitinol wire frame covered with ePTFE, conforms to the adjacent, native anatomy facilitating high closure rates with rapid tissue ingrowth with zero reported cardiac erosions, Gore said in a press release.
The device received US Food and Drug Administration (FDA) premarket approval in 2018 for the percutaneous closure of PFO to reduce the risk of recurrent stroke in select patients. It is also approved in the European Union (EU) for percutaneous closure of PFO. Furthermore, it is approved in the USA and EU for closure of a type of atrial septal defect.