First-In-Human Study to evaluate the safety and feasibility of EnCompass-S2 ARFA PFA (Advanced Radiofrequency Ablation Pulsed Field Ablation) Dual Energy Clamp in patients undergoing cardiac ablation during a concomitant cardiac surgical procedure. (EnCompass-S2 FIH)

Abstract

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide. Surgical ablation for the treatment of AF during concomitant cardiac surgery is a class I recommendation per Society of Thoracic Surgeons (STS) and Heart Rhythm Society (HRS) guidelines. The AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System will be used to treat AF as part of planned cardiac surgery. The objective of this study is to evaluate the safety and feasibility of the Isolator Synergy EnCompass-S2 AFRA PFA Dual Energy System in participants with atrial fibrillation (AF) undergoing cardiac ablation concomitant to cardiac surgery.