Safety, Effectiveness, and Clinical Workflow with a Balloon-Based Pulsed Field Ablation System: A Single-Center Experience.

A balloon-based pulsed field ablation (PFA) system with tissue proximity and mapping integration is currently undergoing clinical study. The initial 47 cases performed by a single operator identified important procedural workflow and system features that allow for the efficient adoption of this new catheter ablation technology resulting in an average procedure time including a 20 minute waiting period of 106.4 ± 21.1 minutes, with an average of 18.2 ± 3.1 applications per patient. This initial clinical study experience demonstrated this PFA system was safe and acutely effective in pulmonary vein isolation for the treatment of atrial fibrillation.