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

<h2>Abstract</h2><h3>Background</h3> A novel ultra-high resolution mapping system (Clarysense, Biosense Webster, Inc.) consists of a 100-electrode deflectable bidirectional basket-shaped high-density mapping catheter, incorporating a central TRUEref electrode, integrated with the CARTO 3 System. <h3>Objective</h3> To assess the clinical safety and performance of the novel system for mapping in complex atrial and ventricular arrhythmias. <h3>Methods</h3> 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 investigator's standard of care. The primary effectiveness endpoint was completion of preablation electroanatomical mapping without resorting to a nonstudy catheter. The primary safety endpoint was incidence of device-related serious adverse events (SAEs) within 7 days. Physician feedback on catheter performance was collected via a 7-point Likert scale. <h3>Results</h3> 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 23/30 atrial arrhythmia participants. One SAE of transient complete atrioventricular block was reported in a persistent atrial fibrillation patient during preablation mapping, with full recovery. Physician feedback indicated the device met or exceeded expectations for signal quality; most responders rated highly on bipolar signal quality in atria and noise encountered. <h3>Conclusion</h3> 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.