Preventing Atrial Fibrillation After Cardiac Surgery Using the EnCompass Clamp and AtriClip Devices in Patients Aged 65 and Older

What this Trial Is About

Post Operative Atrial Fibrillation POAF is a frequent complication after cardiac surgery, affecting over half of patients depending on their baseline health and surgery type. This trial aims to evaluate if adding prophylactic ablation and exclusion of the Left Atrial Appendage during routine cardiac surgery can reduce the occurrence of POAF and clinical atrial fibrillation in patients aged 65 and older who are at risk but have not yet developed AF. Participants will undergo either the standard cardiac surgery alone or cardiac surgery combined with the Isolator Synergy EnCompass Ablation System and AtriClip Left Atrial Appendage Exclusion System. The ablation and exclusion procedures are performed at the time of the planned cardiac surgery. This study uses a randomized design to compare these two approaches in preventing AF after surgery. Throughout the study, participants will be monitored for safety and effectiveness outcomes within 30 days following surgery, focusing on the incidence of atrial fibrillation and any complications. A longer-term follow-up extending up to three years will assess sustained effectiveness. The total study duration extends through to 2029, with scheduled evaluations to track the participants heart rhythm status and overall health after their cardiac surgery.

BoxX-NoAF Clinical Trial