Trial Purpose and Description
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs).
- Appropriate ASD anatomy Note: Additional Inclusion Criteria may apply
- Absence of concurrent cardiac conditions that could elevate morbidity/mortality beyond what is common for ASD Note: Additional Exclusion Criteria may apply
W.L. Gore & Associates, Inc.
Start Date: 07/11/2017
End Date: 12/31/2021
Last Updated: 02/22/2018
Study HIC#: 2000020129