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PFO Closure Device
PFO Closure Device for Migraine (RELIEF Trial)
N/A
Waitlist Available
Led By Robert Sommer, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject's symptoms meet International Classification of Headache Disorders - 3 (ICHD-3) Diagnostic Criteria for migraine with or without aura.
Subject is 18-55 years of age at the screening visit.
Must not have
Subject is currently taking a P2Y12 inhibitor (See APPENDIX B).
Subject has documented right-to-left shunt source in addition to PFO, such as pulmonary arteriovenous malformation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Summary
This trial is testing a new device to see if it can relieve migraine headaches. The study is comparing the device to a placebo and sham (fake) device.
Who is the study for?
This trial is for individuals aged 18-55 with a history of migraines linked to a heart condition called Patent Foramen Ovale (PFO). Participants must have tried and failed two migraine prevention medications, be able to follow the study protocol, use birth control if applicable, and not be planning pregnancy or surgery during the study. They cannot join if they've had strokes, certain heart issues, uncontrolled hypertension, severe liver problems, drug abuse issues or are on specific blood thinners.
What is being tested?
The GORE® CARDIOFORM Septal Occluder device is being tested in this study to see if it can help relieve migraine headaches. Participants will either receive the actual device closure procedure or a sham (fake) procedure as part of a randomized controlled trial. Additionally, they'll take antiplatelet medication like clopidogrel or prasugrel.
What are the potential side effects?
Possible side effects include reactions related to the occluder device implantation such as discomfort at the site of insertion and risks associated with heart procedures. The antiplatelet medications may increase bleeding risk and cause bruising more easily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My headaches are diagnosed as migraines, with or without aura.
Select...
I am between 18 and 55 years old.
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I am not pregnant, breastfeeding, or planning to become pregnant during the study.
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I have had migraines for at least one year.
Select...
I experience migraines more than once a week.
Select...
My migraines started before I turned 50.
Select...
I am not planning any surgeries while participating in the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on a P2Y12 inhibitor medication.
Select...
I have a condition where blood bypasses my lungs and mixes inside my heart.
Select...
I need to take medication regularly to prevent blood clots.
Select...
I have had significant bleeding or an active ulcer in the last 6 months.
Select...
I understand the study requirements and have always followed medical advice.
Select...
My liver is not working well, shown by high bilirubin or prolonged PT/PTT tests.
Select...
I've used opioids, marijuana, or butalbital for migraines at least 4 times a month in the last 6 months.
Select...
I have a history of stroke, TIA, or brain bleeding.
Select...
I have an infection that cannot be treated.
Select...
I need to take NSAIDs every day.
Select...
I need daily blood thinner medication for a heart condition.
Select...
I have a specific type of headache disorder like hemicrania continua.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure
Headache
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test ArmExperimental Treatment2 Interventions
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
Group II: Control ArmPlacebo Group2 Interventions
Sham device PFO closure (PFO not closed)
Find a Location
Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,782 Total Patients Enrolled
Robert Sommer, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
293 Total Patients Enrolled
David Dodick, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
379 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a hole in your heart that allows blood to flow in the wrong direction, as confirmed by a special heart test.I am currently on a P2Y12 inhibitor medication.You are willing to keep an electronic record of your migraine headaches on a daily basis.I have a condition where blood bypasses my lungs and mixes inside my heart.I have a heart rhythm problem that isn't well-controlled by my current treatment.I've been on a stable migraine prevention medication dose for 2+ months and will continue it during the study.I need to take medication regularly to prevent blood clots.My headaches are diagnosed as migraines, with or without aura.You have had low platelet count in the past year or your platelet count is currently below 100,000 mm3.I have tried at least two different types of migraine prevention medications without success.I have had significant bleeding or an active ulcer in the last 6 months.I am between 18 and 55 years old.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I have a medical condition known to cause headaches.I understand the study requirements and have always followed medical advice.My liver is not working well, shown by high bilirubin or prolonged PT/PTT tests.I've used opioids, marijuana, or butalbital for migraines at least 4 times a month in the last 6 months.I have had migraines for at least one year.You are allergic to thienopyridines or have a condition that makes it unsafe for you to take them.I experience migraines more than once a week.I have a history of stroke, TIA, or brain bleeding.I have an infection that cannot be treated.I am willing and able to follow the study rules and can be reached by phone.My migraines started before I turned 50.I need to take NSAIDs every day.I need daily blood thinner medication for a heart condition.I am not planning any surgeries while participating in the study.I agree to use birth control or abstain from sex during the study.My doctor thinks closing my heart defect is unsafe due to high lung blood pressure.I have a specific type of headache disorder like hemicrania continua.The doctor thinks that the shape of your heart is not suitable for the GORE® CARDIOFORM Septal Occluder to be placed safely.
Research Study Groups:
This trial has the following groups:- Group 1: Test Arm
- Group 2: Control Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Patent Foramen Ovale Patient Testimony for trial: Trial Name: NCT04100135 — N/A
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