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PFO Closure Device for Migraine (RELIEF Trial)
RELIEF Trial 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.
RELIEF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRELIEF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RELIEF Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Test Arm
- Group 2: Control Arm
- 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.
Frequently Asked Questions
What sort of ailments is Actual device PFO closure typically utilized to address?
"Device PFO closure is typically used to address myocardial infarction, yet there are other applications for this medical intervention. These include stroke prevention and the reduction of atherothrombotic events."
Are there any current vacancies within the scope of this trial?
"According to the clinicaltrials.gov database, this active trial was first listed on February 5th 2021 and most recently updated on December 1st 2022."
How many centers are currently conducting this research study?
"Patients can join this trial at SJH Cardiology Associates in Liverpool, New york, Columbia University Medical Center in New York and Kentucky, as well as the University of Kentucky Research Foundation located in Lexington. Moreover, there are 5 additional clinical sites that offer participation."
What criteria must one fulfill to be eligible for participation in this trial?
"This medical trial is currently receiving applications from those aged 18 to 55 that suffer from migraine. The objective is to accept a maximum of 150 participants by the end of recruitment."
Has there been precedent for employing Actual device PFO closure in medical research?
"Currently, 60 different research studies concerning Actual device PFO closure are running. Of these trials, 14 are in Phase 3. Although the majority of these investigations take place in Beijing, there exist 814 sites conducting experiments with this therapeutic procedure."
What is the size of the participant pool in this research endeavor?
"W.L.Gore & Associates are in charge of conducting this trial at two separate locations, SJH Cardiology Associates located in Liverpool and Columbia University Medical Center situated in New york, Kentucky; necessitating the recruitment of 150 patients that meet the inclusion criteria for participation."
Is the age range for this investigation restricted to 35 or younger?
"The study's boundaries for eligibility set the age range at 18 to 55 years old. There are 35 trials that accept patients younger than 18 and 187 studies recruiting those older than 65."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
Why did patients apply to this trial?
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