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GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04100135
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : November 6, 2020
Information provided by (Responsible Party):
W.L.Gore & Associates

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

Condition or disease Intervention/treatment Phase
Migraine Patent Foramen Ovale Device: Actual device PFO closure Drug: Thienopyridine (clopidogrel or prasugrel) Device: Sham device PFO closure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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 Name: 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

Primary Outcome Measures :
  1. Reduction in Migraine Headache Days: mean reduction in the number of migraine headache days per month from baseline to follow-up [ Time Frame: Week 40 ]
    Primary Efficacy Endpoint

  2. Number of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure from procedure through 30 days post-procedure [ Time Frame: 30 days post-procedure ]
    Primary Safety Endpoint

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 by history - headache day defined as: headache that meets ICHD-3 criteria 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 controlled trial (See APPENDIX A).
  9. Subject must exhibit stable dosage on their preventative migraine medication for at least two months prior to the screening visit and agree to continue preventative medication at current dosage throughout the duration of the study.
  10. Female subjects are currently not pregnant 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04100135

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Contact: Erik Ramirez 480-828-5597
Contact: Kathy Sullivan 928-814-6669

Sponsors and Collaborators
W.L.Gore & Associates
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Principal Investigator: Robert Sommer, MD Columbia University
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Responsible Party: W.L.Gore & Associates Identifier: NCT04100135    
Other Study ID Numbers: GSO 17-03
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Migraine Disorders
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs