Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

NCT ID: NCT05529901

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2029-08-31

Brief 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.

Conditions

Stroke; PFO - Patent Foramen Ovale; Cryptogenic Stroke; TIA

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

GORE® CARDIOFORM Septal Occluder

Patients for whom the device is used (implanted or used by not implanted) during the enrollment period of this post-marketing surveillance will be considered eligible for the study

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
• Diagnosed with a PFO

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Okayama University Hospital

Okayama, , Japan

Countries

Japan

Other Identifiers

JPS 21-08

Identifier Type: -

Identifier Source: org_study_id