GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Study identification
- NCT ID
- NCT04100135
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 7 participants
Conditions and interventions
Interventions
- Actual device PFO closure Device
- Thienopyridine (clopidogrel or prasugrel) Drug
- Sham device PFO closure Device
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 5, 2021 (Actual)
- Primary completion
- Aug 15, 2024 (Actual)
- Completion
- Aug 15, 2024 (Actual)
- Last update posted
- Jun 9, 2026
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 Jun 9, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04100135 live on ClinicalTrials.gov.