Abstract 17921: First Human Assessment of a Multi-Electrode RF Balloon Catheter System to Treat Symptomatic Paroxysmal Atrial Fibrillation

Background: Despite advances in ablation technology, current systems are limited. We evaluated an irrigated multi-electrode RF balloon system, real-time visualization, irrigation and ability to pace for pulmonary vein (PV) isolation in humans. Methods: Six patients with documented history of paroxysmal atrial fibrillation (PAF) were enrolled in March 2016 in Asuncion, Paraguay (n=4), Christchurch, New Zealand (n=2). The balloon was inflated to 28mm, tissue contact was assessed using real-time visualization with built-in cameras. The ablation pattern was selected based on electrode contact, bipolar ablation using RF was delivered to the PV antrum. PV isolation assessed with entrance block. The primary safety endpoint was absence of SAEs at 7 days and 30 days. Acute procedure success was assessed by rate of PV isolation. Results: PV isolation was achieved in 96% (23/24 veins) using this system. Average procedure time was 2:38, left atrial dwell time averaged 1:26. Patients received an average of 2.8 applications of RF delivered per PV. There were no SAEs at 7 days and 30 days. Conclusions: The multi-electrode RF balloon is able to achieve PV isolation. Visualization via the balloon allowed confirmation of electrode apposition. No adverse events were seen at 7 days and 30 days. The system allowed for quick ablation without excessive catheter manipulations. From this initial use, further clinical use is warranted.