GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Stopped: Dissatisfactory enrollment rate with no safety concerns
United States7 participantsStarted 2021-02-05
Plain-language summary
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — does that mean there were safety concerns with the GORE CARDIOFORM device for migraine, or was it stopped for a different reason, and what does that mean for my situation?
2Since this study was specifically looking at whether closing a patent foramen ovale reduces the number of migraine headache days, what does my doctor think the current evidence says about PFO closure as a migraine treatment, given that this trial didn't complete?
3The trial was measuring serious adverse events as a key safety outcome — what are the known risks of PFO closure procedures in general, and how should I weigh those risks against my current migraine burden?
4Are there completed trials or approved treatments I should consider first before pursuing PFO closure for migraines, especially since this particular study didn't reach its conclusion?
5If I do have a PFO, how does my doctor determine whether it's likely contributing to my migraines, and is closing it something that would still be considered for me outside of a clinical trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).
Exclusion criteria
. Subject is currently enrolled in any pre-approval investigational study. (Does not apply to long-term post-market studies unless participation might interfere clinically with the RELIEF endpoints.)
. Subject has known organic issues which may cause headaches (e.g., temporo-mandibular joint, brain tumor, cervical spinal issues, known seizure disorder, etc.).
. Subjects with hemicrania continua, post-traumatic headache, or other trigeminal autonomic cephalalgia secondary headache disorders.
. Subject has known hypersensitivity or contraindication to thienopyridines.
. Subject is currently taking a P2Y12 inhibitor (See APPENDIX B).
. Subject has need for chronic oral anticoagulation therapy (e.g., atrial fibrillation, mechanical heart valve, etc.) (See APPENDIX B).
. Subject has need for chronic antiplatelet therapy.
. Subject has need for daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (See APPENDIX B).