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Study Design of the Man and Machine Trial: A Prospective International Controlled Noninferiority Trial Comparing Manual with Robotic Catheter Ablation for Treatment of Atrial Fibrillation

Study Design of the Man and Machine Trial. Background: Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug‐resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation.