Pulse Biosciences CellFX nsPFA Cardiac Surgery Clamp System for Treating Atrial Fibrillation During Heart Surgery

What this Trial Is About

Researchers are evaluating the CellFX nsPFA Cardiac Surgery System for treating atrial fibrillation AF in adults undergoing heart surgery. This prospective, multicenter, non-randomized single-arm study focuses on adults aged 18 to 85 with paroxysmal or persistent AF who are scheduled for cardiac surgery involving cardiopulmonary bypass. The goal is to assess the safety and effectiveness of this device during concomitant cardiac surgical procedures. Participants will receive cardiac ablation using the CellFX nsPFA Cardiac Clamp system during their open-heart surgery. The procedure includes isolation of the left and right pulmonary veins and the left atrial posterior wall via roof and floor lesions, forming a box lesion set. Left atrial appendage exclusion or removal is also performed. The left atrial posterior wall isolation can be achieved by either an epicardial lesion or a combined epicardial and endocardial approach when the left atrium is open. During the study, participants will be monitored for freedom from atrial arrhythmias lasting more than 30 seconds and freedom from increased use of certain antiarrhythmic drugs from 3 to 6 months after the procedure. Safety is tracked by recording major adverse events such as death, stroke, heart attack, or bleeding within 30 days after surgery. Follow-up includes assessments of electrical isolation immediately after ablation and patient-reported quality of life at 6 and 12 months. The total participation period includes baseline, procedure, and follow-up visits up to 12 months.

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation