Clinical Trial

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Study acronym: GSO-PFO PMS
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-09-02; most recent amendment 2025-11-18.
Status change: Recruiting → Active, Not Recruiting 2025-02-10
Status change: Not Yet Recruiting → Recruiting 2022-12-06
Trial Details
NCT Number NCT05529901
Lead Sponsor W.L.Gore & Associates
Conditions Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
Enrollment 300 participants
Start Date 2022-10-03
Primary Completion 2029-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2025-11-20