MigraineRELIEFNCT04100135

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study

A study testing Actual device PFO closure and Thienopyridine (clopidogrel or prasugrel) in people with Migraine and Patent Foramen Ovale, run by W.L.Gore & Associates at 15 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
What is being tested?: Actual device PFO closure and Thienopyridine (clopidogrel or prasugrel)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 15 sitesUnited States
Study dates: 5 Feb 2021to 15 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is 18-55 years of age at the screening visit.
Subject is willing and capable of complying with the study protocol requirements, including the specified follow-up period, and can be contacted by telephone.
Subject signed an Informed Consent Form prior to study participation.
Subject's symptoms meet International Classification of Headache Disorders - 3 (ICHD-3) Diagnostic Criteria for migraine with or without aura.
Subject has at least one year of migraine symptom duration.
Subject had migraine onset younger than 50 years of age.

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Subject has more than one migraine headache day per week on average by history - headache day defined as: headache that meets ICHD-3 criteria for migraine or probable migraine with or without aura and lasts at least four hours or administration of acute medication before four hours (regardless of clinical response to acute medication).
Subject has tried and failed at least two preventive medications at adequate dosage for an adequate duration, in the judgement of the study site neurologist, and be from two separate classifications of the following classes of drugs: antidepressants, antihypertensive, anticonvulsant, onabotulinumtoxin A, CGRP inhibitors or other treatments with at least one positive randomized placebo-controlled trial (See APPENDIX A).
Subject must exhibit stable dosage on their preventive migraine medication for at least two months prior to the screening visit and agree to continue preventive medication at current dosage throughout the duration of the study.
Female subjects are currently not pregnant, breastfeeding or lactating and not planning pregnancy during their participation in the study.
Female subjects capable of becoming pregnant agree to use birth control or abstinence during their participation in the study.
Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing Transthoracic Echocardiography (TTE) or transesophageal echocardiography (TEE), demonstrating right-to-left shunting.
Subject is willing to complete daily electronic migraine headache log.
Subject is not planning surgery during their participation the study.

Who cannot join

Subject is currently enrolled in any pre-approval investigational study. (Does not apply to long-term post-market studies unless participation might interfere clinically with the RELIEF endpoints.)
Subject has known organic issues which may cause headaches (e.g., temporo-mandibular joint, brain tumor, cervical spinal issues, known seizure disorder, etc.).
Subjects with hemicrania continua, post-traumatic headache, or other trigeminal autonomic cephalalgia secondary headache disorders.
Subject has known hypersensitivity or contraindication to thienopyridines.
Subject is currently taking a P2Y12 inhibitor (See APPENDIX B).
Subject has need for chronic oral anticoagulation therapy (e.g., atrial fibrillation, mechanical heart valve, etc.) (See APPENDIX B).

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Subject has need for chronic antiplatelet therapy.
Subject has need for daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (See APPENDIX B).
Subject has a history of thrombocytopenia within one year, or platelet count <100,000 mm3 identified during the screening phase.
Subject has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT/PTT or total bilirubin > 3.0 mg/dL identified during the screening phase.
Subject has any history of stroke, TIA, or intracranial hemorrhage.
Subject has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, left atrial appendage closure device OR any cardiac surgical or interventional history which, in the investigator's opinion, would preclude them from study participation.
Subject has documented right-to-left shunt source in addition to PFO, such as pulmonary arteriovenous malformation.
Subject used opioids, marijuana (medical or recreational) or butalbital-containing medications for acute migraine headache treatment four or more times per month on average within the past six months.
Subject abuses alcohol and/or drugs in the opinion of the Investigator.
Subject is unable to understand the study requirements or has a history of non-compliance with medical advice.
Subject has a history of clinically significant bleeding within six months of the screening visit, any active bleeding, or active peptic ulcer disease.
Subject has an uncontrolled arrhythmia or, if on therapy, within the past 90 days has evidence of arrhythmia control failure (e.g., supraventricular tachycardia while under rate control or atrial fibrillation while under rhythm control).
Subject has elevated pulmonary vascular resistance (PVR) which, in the opinion of the implanting physician, precludes safe defect closure.
Subject has uncontrolled systemic hypertension at the time of screening, in the opinion of the investigator.
In the opinion of the Investigator, patient has anatomic criteria identified during the screening evaluation and/or the screening echocardiogram that are unfavorable for successful placement of the GORE® CARDIOFORM Septal Occluder.
Subject has active infection at the time of screening that cannot be treated.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

University of Michigan Hospital
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
University at Buffalo
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
South Denver Cardiology
Denver, Colorado, 80120
SJH Cardiology Associates
Liverpool, New York, 13088
UCLA Health
Los Angeles, California, 90095
Medical Center of the Rockies
Loveland, Colorado, 80538
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale University School of Medicine
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Santa Barbara Cottage Hospital Research Institute
Santa Barbara, California, 93105
Mercy One Iowa Heart Center
West Des Moines, Iowa, 50314

Other trials in United States

About this study

Official title: GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Conditions: Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
Being tested: Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel), Sham device PFO closure
Keywords: Migraine, PFO, Patent Foramen Ovale, Migraine aura
Medical subject headings: Migraine Disorders, Foramen Ovale, Patent, Migraine with Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Actual device PFO closureDevice
Also called GORE® CARDIOFORM Septal Occluder
Actual PFO closure with the GORE® CARDIOFORM Septal Occluder
Thienopyridine (clopidogrel or prasugrel)Drug
Also called Plavix, Effient
Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure
Sham device PFO closureDevice
Sham (simulated) device PFO closure with result of no device implantation and no PFO closure

Study groups in NCT04100135
Study group	Role	What they receive
Test Arm	Experimental	Device PFO closure with the GORE® CARDIOFORM Septal Occluder Receives: Device: Actual device PFO closure; Drug: Thienopyridine (clopidogrel or prasugrel)
Control Arm	Sham comparator	Sham device PFO closure (PFO not closed) Receives: Drug: Thienopyridine (clopidogrel or prasugrel); Device: Sham device PFO closure

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in Migraine Headache Days (Efficacy)
Mean reduction in the number of migraine headache days per month from baseline to follow-up
Measured: Week 40
Serious Adverse Events (Safety)
Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure
Measured: 30 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202115 Aug 2024

First posted24 Sep 2019
Study start5 Feb 2021
Primary completion15 Aug 2024
Study completion15 Aug 2024

Why it stopped: Dissatisfactory enrollment rate with no safety concerns

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04100135
Sponsor's protocol ID: GSO 17-03
Acronym: RELIEF
Status last verified: Jun 2026
First submitted: 20 Sep 2019
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
Not yet recruiting
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
Chronic Migraine Headache
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
Not yet recruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches
ClinicalTrials.gov ID: NCT04100135
Acronym / sponsor ID: RELIEF / GSO 17-03
Conditions: Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
Keywords: Migraine, PFO, Patent Foramen Ovale, Migraine aura
Study type: Interventional
Recruitment status: TerminatedReason stopped: Dissatisfactory enrollment rate with no safety concerns
Enrolment: 7 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: 5 Feb 2021 (actual)
Primary completion: 15 Aug 2024 (actual)
Study completion: 15 Aug 2024 (actual)
First posted: 24 Sep 2019 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Test Arm	Experimental	Device: Actual device PFO closure, Drug: Thienopyridine (clopidogrel or prasugrel)Device PFO closure with the GORE® CARDIOFORM Septal Occluder
Control Arm	Sham comparator	Drug: Thienopyridine (clopidogrel or prasugrel), Device: Sham device PFO closureSham device PFO closure (PFO not closed)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Subject is 18-55 years of age at the screening visit.
Subject is willing and capable of complying with the study protocol requirements, including the specified follow-up period, and can be contacted by telephone.
Subject signed an Informed Consent Form prior to study participation.
Subject's symptoms meet International Classification of Headache Disorders - 3 (ICHD-3) Diagnostic Criteria for migraine with or without aura.
Subject has at least one year of migraine symptom duration.

Key exclusion criteria (22 listed)

Subject is currently enrolled in any pre-approval investigational study. (Does not apply to long-term post-market studies unless participation might interfere clinically with the RELIEF endpoints.)
Subject has known organic issues which may cause headaches (e.g., temporo-mandibular joint, brain tumor, cervical spinal issues, known seizure disorder, etc.).
Subjects with hemicrania continua, post-traumatic headache, or other trigeminal autonomic cephalalgia secondary headache disorders.
Subject has known hypersensitivity or contraindication to thienopyridines.
Subject is currently taking a P2Y12 inhibitor (See APPENDIX B).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Actual device PFO closureAlso: GORE® CARDIOFORM Septal OccluderActual PFO closure with the GORE® CARDIOFORM Septal Occluder	Device	Test Arm
Thienopyridine (clopidogrel or prasugrel)Also: Plavix, EffientThienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure	Drug	Control Arm, Test Arm
Sham device PFO closureSham (simulated) device PFO closure with result of no device implantation and no PFO closure	Device	Control Arm

Primary outcome

Reduction in Migraine Headache Days (Efficacy)
Time frame: Week 40
Mean reduction in the number of migraine headache days per month from baseline to follow-up
Serious Adverse Events (Safety)
Time frame: 30 days post-procedure
Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Arm	1	1
Control Arm	1	1

Primary outcome: Reduction in Migraine Headache Days (Efficacy)

Time frame: Week 40

Population analysed: No subjects evaluable for this outcome.

Primary outcome: Serious Adverse Events (Safety)

Time frame: 30 days post-procedure. Count of participants. Unit: Participants

Measure	Test Arm n = 1	Control Arm n = 1
Value	0	0

Adverse events

Time frame: From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Arm	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Control Arm	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): The study was terminated prematurely with only one subject randomized to the device. The reason for premature termination was dissatisfactory enrollment rate, and not based on any safety or efficacy concerns. Due to the early study termination and limited data, the GORE® CARDIOFORM Septal Occluder for migraine headache relief could not be analyzed; therefore, this study could not report any conclusion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Migraine

RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
Not yet recruiting
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
Chronic Migraine Headache
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
Not yet recruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Sommer, MD principal investigator

Columbia University

David Dodick, MD principal investigator

Mayo Clinic

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Actual device PFO closure and Thienopyridine (clopidogrel or prasugrel) in people with Migraine and Patent Foramen Ovale, run by W.L.Gore & Associates at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Migraine Headache Days (Efficacy) (time frame: Week 40). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04100135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.