NCT05529901

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2022-10-03
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2022-09-07
• Last updated: 2025-11-20

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study