The study is testing a device called the reSept ASD Occluder to fix a heart problem known as secundum atrial septal defect (ASD). This condition is a hole in the heart's wall separating the top two chambers, which can cause blood to flow differently than it should. This study aims to see if this device is safe and works well, comparing it to other similar devices already approved by the FDA.
To participate, you must be under 85 years old, weigh at least 33 lbs, and have a specific type of heart hole that needs treatment. You also need to be able to take certain medications like aspirin and heparin, and have a heart structure that can support the device. You should not be pregnant or have serious heart valve problems or other major health issues.
- The study involves multiple visits to the clinic and requires taking medications for up to 6 months.
- Participants will be closely monitored to ensure safety and effectiveness of the treatment.
- Compensation details are not specified, but participants must comply with study requirements.