GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
• Subject is 18-55 years of age at the screening visit.
• Subject is willing and capable of complying with the study protocol requirements, including the specified follow-up period, and can be contacted by telephone.
• Subject signed an Informed Consent Form prior to study participation.
• Subject's symptoms meet International Classification of Headache Disorders - 3 (ICHD-3) Diagnostic Criteria for migraine with or without aura.
• Subject has at least one year of migraine symptom duration.
• Subject had migraine onset younger than 50 years of age.
• Subject has more than one migraine headache day per week on average by history - headache day defined as: headache that meets ICHD-3 criteria for migraine or probable migraine with or without aura and lasts at least four hours or administration of acute medication before four hours (regardless of clinical response to acute medication).
• Subject has tried and failed at least two preventive medications at adequate dosage for an adequate duration, in the judgement of the study site neurologist, and be from two separate classifications of the following classes of drugs: antidepressants, antihypertensive, anticonvulsant, onabotulinumtoxin A, CGRP inhibitors or other treatments with at least one positive randomized placebo-controlled trial (See APPENDIX A).
• Subject must exhibit stable dosage on their preventive migraine medication for at least two months prior to the screening visit and agree to continue preventive medication at current dosage throughout the duration of the study.
• Female subjects are currently not pregnant, breastfeeding or lactating and not planning pregnancy during their participation in the study.
• Female subjects capable of becoming pregnant agree to use birth control or abstinence during their participation in the study.
• Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing Transthoracic Echocardiography (TTE) or transesophageal echocardiography (TEE), demonstrating right-to-left shunting.
• Subject is willing to complete daily electronic migraine headache log.
• Subject is not planning surgery during their participation the study.