GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF)

June 5, 2026 updated by: W.L.Gore & Associates

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subject is 18-55 years of age at the screening visit.
  2. Subject is willing and capable of complying with the study protocol requirements, including the specified follow-up period, and can be contacted by telephone.
  3. Subject signed an Informed Consent Form prior to study participation.
  4. Subject's symptoms meet International Classification of Headache Disorders - 3 (ICHD-3) Diagnostic Criteria for migraine with or without aura.
  5. Subject has at least one year of migraine symptom duration.
  6. Subject had migraine onset younger than 50 years of age.
  7. 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).
  8. 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).
  9. 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.
  10. Female subjects are currently not pregnant, breastfeeding or lactating and not planning pregnancy during their participation in the study.
  11. Female subjects capable of becoming pregnant agree to use birth control or abstinence during their participation in the study.
  12. 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.
  13. Subject is willing to complete daily electronic migraine headache log.
  14. Subject is not planning surgery during their participation the study.

Exclusion Criteria:

  1. 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.)
  2. Subject has known organic issues which may cause headaches (e.g., temporo-mandibular joint, brain tumor, cervical spinal issues, known seizure disorder, etc.).
  3. Subjects with hemicrania continua, post-traumatic headache, or other trigeminal autonomic cephalalgia secondary headache disorders.
  4. Subject has known hypersensitivity or contraindication to thienopyridines.
  5. Subject is currently taking a P2Y12 inhibitor (See APPENDIX B).
  6. Subject has need for chronic oral anticoagulation therapy (e.g., atrial fibrillation, mechanical heart valve, etc.) (See APPENDIX B).
  7. Subject has need for chronic antiplatelet therapy.
  8. Subject has need for daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (See APPENDIX B).
  9. Subject has a history of thrombocytopenia within one year, or platelet count <100,000 mm3 identified during the screening phase.
  10. 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.
  11. Subject has any history of stroke, TIA, or intracranial hemorrhage.
  12. 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.
  13. Subject has documented right-to-left shunt source in addition to PFO, such as pulmonary arteriovenous malformation.
  14. 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.
  15. Subject abuses alcohol and/or drugs in the opinion of the Investigator.
  16. Subject is unable to understand the study requirements or has a history of non-compliance with medical advice.
  17. Subject has a history of clinically significant bleeding within six months of the screening visit, any active bleeding, or active peptic ulcer disease.
  18. 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).
  19. Subject has elevated pulmonary vascular resistance (PVR) which, in the opinion of the implanting physician, precludes safe defect closure.
  20. Subject has uncontrolled systemic hypertension at the time of screening, in the opinion of the investigator.
  21. 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.
  22. Subject has active infection at the time of screening that cannot be treated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Arm
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
Device: Actual device PFO closure
Actual PFO closure with the GORE® CARDIOFORM Septal Occluder
Other Names:
  • GORE® CARDIOFORM Septal Occluder
Drug: Thienopyridine (clopidogrel or prasugrel)
Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure
Other Names:
  • Plavix
  • Effient
Sham Comparator: Control Arm
Sham device PFO closure (PFO not closed)
Drug: Thienopyridine (clopidogrel or prasugrel)
Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure
Other Names:
  • Plavix
  • Effient
Device: Sham device PFO closure
Sham (simulated) device PFO closure with result of no device implantation and no PFO closure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Week 40
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
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.L.Gore & Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Sommer, MD, Columbia University
  • Principal Investigator: David Dodick, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GSO 17-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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