This study looks at the safety and effectiveness of using the reSept ASD Occluder to treat a heart problem called secundum atrial septal defect (ASD). ASD is a hole in the heart between the upper chambers. The study will compare results with other devices approved by the FDA, which is the agency that checks if medical devices are safe.
The study has some rules for who can join. You must be under 85 years old, weigh at least 33 pounds, and have a specific type of ASD. If you are a female and can have children, you will need a pregnancy test. You cannot join if you have certain heart problems, infections, or are pregnant. You also need to be able to take medications like aspirin and heparin.
- The study is done in multiple places and has three stages.
- Participants must take certain medications before and after the procedure.
- You need to give permission to join the study, or a parent/guardian must do so if you are a minor.