PFO Closure Device for Migraine
(RELIEF Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byRobert Sommer, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: W.L.Gore & Associates

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Eligibility Criteria

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.

Inclusion Criteria

You have a hole in your heart that allows blood to flow in the wrong direction, as confirmed by a special heart test.

You are willing to keep an electronic record of your migraine headaches on a daily basis.

I've been on a stable migraine prevention medication dose for 2+ months and will continue it during the study.

+11 more

Exclusion Criteria

I am currently on a P2Y12 inhibitor medication.

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.

+19 more

Participant Groups

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.

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)

GORE® CARDIOFORM Septal Occluder is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as GORE CARDIOFORM Septal Occluder for:

ostium secundum atrial septal defects (ASDs)
patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism

🇪🇺 Approved in European Union as GORE CARDIOFORM Septal Occluder for:

ostium secundum atrial septal defects (ASDs)
patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism