A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex17 ASD Closure System

What this Trial Is About

This research aims to gather real-world data on the use of the Lifetech CeraFlex17 Closure System in patients with Atrial Septal Defect (ASD) who have received the device since 2019. The study focuses on evaluating the device's clinical application according to approved guidelines in a post-market setting. Participants are patients diagnosed with ASD who have been implanted with the CeraFlex17 ASD Closure System, a device designed for non-surgical closure of atrial septal defects using a transcatheter approach. The study is observational and involves a single group of patients who have already undergone implantation. During the study, researchers will monitor patient outcomes including the success of the procedure six months after implantation, the presence of any residual shunts at various time points up to twelve months, and the occurrence of device or procedure-related adverse events, serious adverse events, device deficiencies, and mortality up to twenty-four months post-implantation. Participants' data will be collected during follow-up visits to assess these outcomes over time.

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