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NCT05529901Active, not recruiting

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
23 Aug 2022
Start date
3 Oct 2022
Primary completion date
Aug 2029
Lead sponsor
W.L.Gore & Associates
Diseases
Stroke
NCT number
NCT05529901

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 3 Oct 2022 to the primary completion date, Aug 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • N/A

Who the study is looking for

  • Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
  • Diagnosed with a PFO
  • Note: Additional Inclusion Criteria may apply

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Okayama University Hospital
Coordinator of this site? Confirm its status
OkayamaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.