W.L. Gore & Associates (Gore) has launched a multicenter, prospective, randomized placebo- and sham-controlled investigational study that will evaluate the safety and efficacy of transcatheter closure of PFO to relieve migraine headaches. The closure will be conducted using the company’s CARDIOFORM septal occluder, a permanently implanted device.

In prepared remarks, the study’s National Principal Investigator, Robert Sommer, MD, said that no previous PFO closure migraine trial has yet included such clearly defined selection criteria designed to identify those patients who are expected to respond to this potential PFO-mediated mechanism most likely. “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," he continued.

The CARDIOFORM septal occluder provides a soft and conformable option for PFO closure, which is 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, according to the company. More than 60,000 of the devices have been sold globally in 11 years of clinical use, and it is FDA approved for use in the percutaneous closure of PFO to reduce the risk of recurrent stroke in select patients. It is also approved in Europe for the percutaneous closure of PFO. Both agencies have approved the device for the closure of a type of atrial septal defect.

The study’s 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 RELIEF study seeks a final enrollment of 150 patients responsive to the study drug, with documented PFO, ages 18 to 55, and with a history of more than one migraine headache per day per week.