B-PO04-016 A NOVEL IRRIGATED GOLD-TIP FORCE SENSING ABLATION SYSTEM DEMONSTRATES CREATION OF SAFE AND EFFECTIVE HIGH-POWER RF LESIONS IN PRE-CLINICAL TESTING

Abstract

A novel irrigated, ablation catheter with a beveled, gold tip and 3-D optical force sensor has been developed. Gold provides more uniform heating, while beveling enhances stability at the tissue interface. Irrigation ports (12) are strategically placed to maximize catheter tip cooling. Evaluate the safety of the irrigated AcQBlate Force Sensing System (Acutus Medical, Carlsbad, CA) in an acute and chronic animal study. In anesthetized swine (n=6) a GLP study of ablation in the left and right atrium was performed using a high-power short duration (HPSD) protocol (30W - 50W). Acute effectiveness was determined by EGM attenuation, impedance change, and evidence of functional block (FB). Acute animals were euthanized post-ablation (n=2), and chronic animals were survived for 30 days (n=4). All animals underwent histopathologic assessment at terminal study. Charge density activation mapping (AcQMap) was performed pre- and post-ablation and prior to chronic animal termination. The mean number of ablations/animal was 42.2 ± 7.7 and effective lesions were demonstrated in all animals. Evidence of FB was demonstrated in 100% of contact and non-contact maps. Histology verified transmural lesions in each animal. All safety endpoints were met. There was no evidence of systemic emboli, steam pops or major complications related to RF energy delivery. Cardiac perforation occurred in 1 acute animal not related to RF energy delivery. The AcQBlate Force Sensing System created safe and effective lesions at HPSD in the animal model. Future research should focus on the impact of gold as a thermal conductor in RF ablation.