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ACTIVE NOT RECRUITING
NCT05529901
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
Sponsor: W.L.Gore & Associates
View on ClinicalTrials.gov
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.
Official title: Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2022-10-03
Completion Date
2029-08
Last Updated
2025-11-20
Healthy Volunteers
No
Interventions
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
Locations (1)
Okayama University Hospital
Okayama, Japan