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PFO Closure Device

PFO Closure Device for Migraine (RELIEF Trial)

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.
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights

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.

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.

RELIEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My headaches are diagnosed as migraines, with or without aura.
I am between 18 and 55 years old.
I am not pregnant, breastfeeding, or planning to become pregnant during the study.
I have had migraines for at least one year.
I experience migraines more than once a week.
My migraines started before I turned 50.
I am not planning any surgeries while participating in the study.

RELIEF Trial Timeline

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

RELIEF 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
95 Previous Clinical Trials
28,177 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