First-in-human experience for cardiac arrhythmia mapping using a novel ultra−high-density globe-shaped catheter from the multicenter COSMOS study

Background: A novel ultra-high-resolution mapping system (Clarysense, Biosense Webster, Inc) has been developed that consists of a 100-electrode deflectable bidirectional basket-shaped high-density mapping catheter that incorporates a central TRUEref electrode and is integrated with the CARTO 3 system. Objective: This study aimed to assess the clinical safety and performance of the novel system for mapping in complex atrial and ventricular arrhythmias. Methods: This prospective, single-arm, multicenter study included patients undergoing catheter mapping and ablation of atrial and ventricular arrhythmias. Mapping was performed with the study catheter, and participants were ablated per the investigator's standard of care. The primary effectiveness endpoint was completion of preablation electroanatomic mapping without resorting to a nonstudy catheter. The primary safety endpoint was the incidence of device-related serious adverse events within 7 days. Physician feedback on catheter performance was collected using a 7-point Likert scale. Results: 40 participants (mean age 58.0 ± 15.73 years; 62.5% male; 30 with atrial arrhythmias, 10 with ventricular arrhythmias) underwent mapping with the study catheter. The primary effectiveness endpoint was achieved in all participants; ≥1 area of interest for mappable rhythms was identified in 23 of 30 participants with atrial arrhythmia. One serious adverse event of transient complete atrioventricular block was reported in a participant with persistent atrial fibrillation during preablation mapping, with full recovery. Physician feedback indicated that the device met or exceeded expectations for signal quality; most responders rated highly on bipolar signal quality in atria and noise encountered. Conclusion: In this first-in-human study, the novel mapping system improved high-density mapping in complex arrhythmias with high-quality signals and map resolution. The catheter exceeded operators' expectations in signal fidelity.