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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

Awards & highlights

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.Check my eligibility

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.See study design

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 below

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My headaches are diagnosed as migraines, with or without aura.

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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.

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I experience migraines more than once a week.

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My migraines started before I turned 50.

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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:

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I am currently on a P2Y12 inhibitor medication.

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I have a condition where blood bypasses my lungs and mixes inside my heart.

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I need to take medication regularly to prevent blood clots.

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I have had significant bleeding or an active ulcer in the last 6 months.

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I understand the study requirements and have always followed medical advice.

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My liver is not working well, shown by high bilirubin or prolonged PT/PTT tests.

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I've used opioids, marijuana, or butalbital for migraines at least 4 times a month in the last 6 months.

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I have a history of stroke, TIA, or brain bleeding.

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I have an infection that cannot be treated.

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I need to take NSAIDs every day.

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I need daily blood thinner medication for a heart condition.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor

95 Previous Clinical Trials

28,176 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

GORE® CARDIOFORM Septal Occluder (PFO Closure Device) Clinical Trial Eligibility Overview. Trial Name: NCT04100135 — N/A

Patent Foramen Ovale Research Study Groups: Test Arm, Control Arm

Patent Foramen Ovale Clinical Trial 2023: GORE® CARDIOFORM Septal Occluder Highlights & Side Effects. Trial Name: NCT04100135 — N/A

GORE® CARDIOFORM Septal Occluder (PFO Closure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04100135 — N/A

Patent Foramen Ovale Patient Testimony for trial: Trial Name: NCT04100135 — N/A

~2 spots leftby Dec 2025

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