Purpose: We aimed to assess the feasibility, safety, and operator feedback of a novel star-shaped high-density mapping catheter containing 48 platinum-iridium mapping electrodes distributed across eight spines.
Methods: This prospective, single-arm, first-in-human study was conducted at five European sites. Primary endpoints were completion of pre-ablation mapping requirements, obtaining clinically indicated mapping with the new catheter without resorting to non-study mapping catheters, and incidence of serious adverse events (SAEs). Physician feedback survey assessed catheter performance, including deployment, ease of use, and mapping results. The subjects were followed for 7 days post-procedure.
Results: Of 31 patients enrolled (11 ventricular tachycardia [VT], 10 scar-related atrial tachycardia [AT]/atypical atrial flutter [AFL], and 10 persistent atrial fibrillation [PsAF]), 28 had study catheter inserted for mapping purposes. Pre-ablation mapping was achieved in 23/28 patients (82.1%). Median of total pre-ablation mapping times were 121.0, 72.5, and 31.5 min for the VT, scar-related AT/atypical AFL, and PsAF subgroups, respectively. More than two-thirds of mapping points acquired were used to generate CARTO maps relevant for ablation. All 16 patients who had conduction channel(s), gaps(s), or critical isthmus identified had the areas successfully mapped. The ability to deploy, maneuver, and reach the atria and ventricles using the catheter was rated positively for most procedures. Only one SAE (heart failure) was reported, unrelated to the device.
Conclusion: The study results demonstrate the feasibility of the OCTARAY catheter to successfully map complex arrhythmias with good safety profile. Operator feedback indicates satisfaction with ease of use and maneuverability of the catheter.
Keywords: Advanced mapping; Atrial fibrillation; Atrial tachycardia; Catheters; Electrodes; Ventricular tachycardia.
© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.