Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

To join this study, participants generally need to be under 85 years old and weigh at least 15 kg (about 33 pounds). Both men and women can take part. Crucially, you must have a secundum ASD that your doctor believes needs treatment and is between 5 to 19 mm wide when first checked, and between 8 to 22 mm at the time of the procedure.

There are also some specific medical requirements, such as having enough healthy heart tissue around the hole for the device to attach properly without affecting other important parts of the heart. You must also be able to take certain medications, like a daily low-dose aspirin, for 6 months after the procedure, and a blood thinner called Heparin during the procedure itself.

You cannot join if you are pregnant, have other severe heart valve problems, very high blood pressure in your lungs, or other serious heart conditions like a recent heart attack or blood clots. Everyone joining, or their parents if they are minors, must be willing to give permission and follow the study instructions.

If you decide to take part, you will receive the reSept ASD Occluder device during a medical procedure. Before, during, and after the procedure, you'll have various check-ups and tests, likely including heart scans (echos). You will need to take a low dose of aspirin daily for six months following the procedure. You'll also be given Heparin, a blood thinner, during the procedure itself. The research team will regularly check how you are doing to make sure the device is working well and that you are recovering safely. The total duration of follow-up for this study is not specified in detail, but it involves monitoring for at least 6 months after the procedure.