ClinicalTrials.gov record
Terminated Not applicable Interventional Accepts healthy volunteers

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study

ClinicalTrials.gov ID: NCT04100135

Public ClinicalTrials.gov record NCT04100135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 8:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT04100135
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
W.L.Gore & Associates
Industry
Enrollment
7 participants

Conditions and interventions

Interventions

  • Actual device PFO closure Device
  • Sham device PFO closure Device
  • Thienopyridine (clopidogrel or prasugrel) Drug

Device · Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 4, 2021
Primary completion
Aug 14, 2024
Completion
Aug 14, 2024
Last update posted
Dec 17, 2024

2021 – 2024

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
Mayo Clinic Arizona Phoenix Arizona 85054
UCLA Health Los Angeles California 90095
Santa Barbara Cottage Hospital Research Institute Santa Barbara California 93105
South Denver Cardiology Denver Colorado 80120
Medical Center of the Rockies Loveland Colorado 80538
Yale University School of Medicine New Haven Connecticut 06510
Mercy One Iowa Heart Center West Des Moines Iowa 50314
Massachusetts General Hospital Boston Massachusetts 02114
University of Michigan Hospital Ann Arbor Michigan 48109
University at Buffalo Buffalo New York 14203
SJH Cardiology Associates Liverpool New York 13088
Columbia University Medical Center New York New York 10032
Medical University of South Carolina Charleston South Carolina 29425
Aurora St Luke's Medical Center Milwaukee Wisconsin 53215
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04100135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2024 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04100135 live on ClinicalTrials.gov.

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