Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder (GSO-PFO PMS)

W.L. Gore & Associates

Status: Active, not recruiting

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

Treatments: Device: GORE® CARDIOFORM Septal Occluder

Study type: Observational

Funder types: Industry

Identifiers

NCT05529901

JPS 21-08

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A