Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
• Diagnosed with a PFO
• Note: Additional Inclusion Criteria may apply
Locations
Other Locations
Japan
Okayama University Hospital
Okayama
Time Frame
Start Date: 2022-10-03
Completion Date: 2029-08
Participants
Target number of participants: 300
Related Therapeutic Areas
Sponsors
Leads: W.L.Gore & Associates