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GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF)

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ClinicalTrials.gov Identifier: NCT04100135
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Description
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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 PFO - Patent Foramen Ovale Device: Actual device PFO closure Drug: Thienopyridine (clopidogrel or prasugrel) Device: Sham device PFO closure Not Applicable

Study Design
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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
Actual Study Start Date : February 5, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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


Outcome Measures
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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 headache days per month from baseline to follow-up [ Time Frame: Week 40 ]
    Primary Efficacy Endpoint

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


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

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04100135


Contacts
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Contact: Erik Ramirez 480-828-5597 relief@wlgore.com

Locations
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United States, Colorado
South Denver Cardiology Not yet recruiting
Denver, Colorado, United States, 80120
Contact: Principal Investigator    303-703-2175      
Medical Center of the Rockies Recruiting
Loveland, Colorado, United States, 80538
Contact: Justin Strote, MD         
United States, Iowa
Mercy One Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50314
Contact: Mark Tannenbaum, MD         
United States, Kentucky
University of Kentucky Research Foundation Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Gurley, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ignacio Inglessis, MD         
United States, New York
SJH Cardiology Associates Recruiting
Liverpool, New York, United States, 13088
Contact: Ayman Iskander, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Robert Sommer, MD       reliefstudy@columbia.edu   
United States, Wisconsin
Aurora St Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Tanvir Bajwa, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael Cinquegrani, MD         
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Robert Sommer, MD Columbia University
Principal Investigator: David Dodick, MD Mayo Clinic
More Information
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT04100135    
Other Study ID Numbers: GSO 17-03
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
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
Keywords provided by W.L.Gore & Associates:
Migraine
PFO
Patent Foramen Ovale
Migraine aura
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
Clopidogrel
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