GORE® CARDIOFORM Septal Occluder Migraine Clinical Study

NCT04100135 | Terminated DMC FDA Device

• 1 other identifier: GSO 17-03
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 15

Brief Summary

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

Keywords

Migraine; PFO; Patent Foramen Ovale; Migraine aura

Outcome Measures

Primary Outcomes (2)

• 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

  Primary Efficacy Endpoint

  Week 40

• Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure

  Primary Safety Endpoint

  30 days post-procedure

Study Arms (2)

Test Arm

EXPERIMENTAL

Device PFO closure with the GORE® CARDIOFORM Septal Occluder

Device: Actual device PFO closure; Drug: Thienopyridine (clopidogrel or prasugrel)

Control Arm

SHAM COMPARATOR

Sham device PFO closure (PFO not closed)

Drug: Thienopyridine (clopidogrel or prasugrel); Device: Sham device PFO closure

Interventions

Actual device PFO closure DEVICE

Actual PFO closure with the GORE® CARDIOFORM Septal Occluder

Also known as: GORE® CARDIOFORM Septal Occluder

Test Arm

Thienopyridine (clopidogrel or prasugrel) DRUG

Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure

Also known as: Plavix, Effient

Control Arm; Test Arm

Sham device PFO closure DEVICE

Sham (simulated) device PFO closure with result of no device implantation and no PFO closure

Control Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (15)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

UCLA Health

Los Angeles, California, 90095, United States

Location

Santa Barbara Cottage Hospital Research Institute

Santa Barbara, California, 93105, United States

Location

South Denver Cardiology

Denver, Colorado, 80120, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Mercy One Iowa Heart Center

West Des Moines, Iowa, 50314, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

SJH Cardiology Associates

Liverpool, New York, 13088, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Foramen Ovale, Patent; Migraine with Aura

Interventions

thienopyridine; Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

Study Officials

• Robert Sommer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• David Dodick, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: February 5, 2021
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)