To participate in this study, you or a loved one must:
There are additional criteria that are reviewed by the study team during your first appointment.
You will meet with a study coordinator at a study site location closest to you. You will learn more about the research study and the benefits and risks of participation. The study coordinator or study doctor will review the Informed Consent Form with you. You will have the chance to ask any questions about this form, and sign once comfortable and willing to participate in the study. Additional screening will be performed to see if you qualify for the clinical study.
Upon eligibility and enrolling in this study, the study medical device known as the Gore® CARDIOFORM Septal Occluder, will be tested. This goal of this device is to close a lingering Patent Foramen Ovale (PFO) in the heart.
The RELIEF Study is designed to last up to two and a half years. It is divided into four phases:
Phase 1: Lasting 8 to 12 weeks, patients will be screened and will complete an electronic headache diary to record how severe and frequent their migraine headaches are.
Phase 2: Lasting around six weeks, patients who qualify after Phase 1 will be given either anticlotting medication or a placebo (an identical capsule with no therapeutic effect) and will complete another migraine headache diary.
Phase 3: Lasting around 40 weeks, patients taking the anticlotting medication who have significant migraine improvement will receive one of the two procedures:
Patients will not know and will not be able to choose which procedure they receive.
Patients will continue taking the anticlotting medication for 24 weeks and complete a shorter migraine headache diary. Then, they will stop taking the anticlotting medication and restart the full migraine diary. They will continue filling it out for 16 more weeks.
Phase 4: Participants will learn which treatment they received.
Patients who received the device will have a long-term follow-up, completing an additional month of migraine headache diaries about two years after the procedure.
Patients who received the control procedure will be offered the study device, study medication and study procedure at no cost. If a patient chooses to have the device implanted, the patient will have a follow-up 30 days after the procedure.
The study centers are located throughout the continental United States. In the future, study centers may be added in other U. S. locations.
You do not have to stop taking your medication unless you are advised to do so by the study center staff or your primary care physician.
There will be no cost to you for the study medication, study device or study procedures.
No, health insurance is not a requirement to participate in either study.
Clinical trials, also known as clinical studies or research studies, are conducted by doctors and researchers funded by industry to see if new medical interventions are safe and effective before being approved for use in the general public. Participation in a clinical trial is completely confidential and will be protected just like any other medical information.
Research studies are used to test new medical interventions for safety, tolerability, and effectiveness before they are approved for use by the public.
You can find out more information about clinical trials by browsing through www.clinicaltrials.gov . This is an online, government database that is managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research studies.
All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits and activities of a research study. Interested participants will sign an Informed Consent Form prior to enrolling in the study. This form shows that a participant understands what will happen during the study and that they can leave the study at any time.
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