Chocholow

Atrial Septal Defect (ASD) is a type of congenital heart defect that can potentially be treated without open-heart surgery. Traditionally, ASD closure has been done surgically, but percutaneous transcatheter occluder devices offer a less invasive alternative. This research evaluates the Lifetech Cera™ ASD Occluder, a device designed for non-surgical closure of ASD, aiming to collect real-world clinical data and confirm its long-term safety and performance while identifying any unknown side effects. The study is a multi-center, single-arm post-market clinical follow-up involving patients who have already received the Lifetech Cera™ ASD Occluder device between January 1, 2020, and December 31, 2023. About 139 participants will be enrolled and followed for a total of 24 months after implantation. This follow-up will provide important information on the procedural success and ongoing safety of the device. Participants will be monitored through scheduled follow-up visits to assess the device's performance and any complications. Researchers will collect clinical data, including procedural success measured at 6 months post-implantation. The total study duration includes an enrollment period of approximately one year and a two-year follow-up post-implantation, ensuring long-term safety monitoring and data collection.