Clinical trialNCT00738894CompletedInterventional

GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients

SponsorW.L.Gore & AssociatesEnrollment664StrokeTransient Ischemic Attack

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA. A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

John F. Rhodes, MD
Medical University of South Carolina
Principal Investigator
clinicaltrials.gov ↗
Lars Søndergaard, MD
Rigshospitalet, Denmark
Principal Investigator
clinicaltrials.gov ↗
Scott E. Kasner, MD, FAHA
University of Pennsylvania Medical Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Denmark

Rigshospitalet
Copenhagen, Denmark

United States

University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Antiplatelet Medical Therapy

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Dec 2008
Primary completion: 24 Apr 2017
Completion: 11 May 2020
Last update posted: 20 Nov 2020
Registered enrollment: 664
Registry id: NCT00738894

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.