Lifetech CeraFlex ASD Closure System Registry A Multi-center, Real-world Study Assessing Clinical Use in Atrial Septal Defect

What this Trial Is About

This research aims to collect real-world clinical data on the use of the Lifetech CeraFlex17 ASD Closure System in patients diagnosed with atrial septal defect (ASD). The study focuses on patients who have received this device between 2019 and 2022, evaluating its use according to approved instructions for use (IFU). The goal is to better understand the device's performance and safety in routine clinical practice. The intervention involves the CeraFlex17 ASD Closure System, which includes two types of occluders: the standard CeraFlex17 ASD Occluder and the CeraFlex17 Multi-fenestrated (Cribriform) ASD Occluder. These devices are designed for non-surgical closure of atrial septal defects using a percutaneous, transcatheter approach. The study is a single-arm registry observing patients who have already been implanted with these devices. Participants will have their clinical data collected and monitored through follow-up visits after hospital discharge, with the data collection expected to finish by the end of 2024 and a final report anticipated in 2025. The main outcome measure is procedural success assessed six months after device implantation. The study involves data release consents and includes tracking follow-up visits to evaluate device effectiveness and safety over time.

Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up