Post-Market Follow-Up Study of the Lifetech Cera10 ASD Occluder for Long-Term Safety and Performance in Atrial Septal Defect Treatment

What this Trial Is About

Atrial Septal Defect ASD is a type of congenital heart defect that may be closed without open-heart surgery. Traditionally, ASD closure was done surgically, but less invasive options like percutaneous transcatheter occluder devices have become available. This research aims to collect real-world clinical data and confirm the long-term safety and performance of the Lifetech Cera153 ASD Occluder, a device used to close ASD without surgery. The study also seeks to identify any previously unknown side effects of this device. Participants in this study will have received the Lifetech Cera153 ASD Occluder between January 2020 and December 2023, following instructions for use. The study is single-armed and observational, planned under the Regulation EU 2017745. Subjects will be followed up for two years after device implantation to track outcomes and safety. The enrollment period is expected to last about one year with a target of 139 participants. During the study, researchers will monitor procedural success six months after implantation and assess successful closure of the defect immediately after the procedure, at hospital discharge, and at 12 months. They will also track new onset arrhythmias requiring treatment, device or procedure-related adverse events and serious adverse events, as well as any deaths from the time of the procedure up to two years post-implantation. Participants must attend follow-up visits as part of the study, with all data collected and processed with their consent.

Cera™ ASD Occluder Post-Market Clinical Follow-Up Study