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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable

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

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: Accepts Healthy Volunteers

• 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.

United States
South Denver Cardiology
Not yet recruiting
Mercy One Iowa Heart Center
West Des Moines
University of Kentucky Research Foundation
New York
SJH Cardiology Associates
Columbia University Medical Center
New York
Contact Information
Erik Ramirez
Kathy Sullivan
Time Frame
Start Date: February 5, 2021
Estimated Completion Date: August 2027
Target number of participants: 150
Experimental: Test Arm
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
Sham Comparator: Control Arm
Sham device PFO closure (PFO not closed)
David Dodick, Robert Sommer
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov

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