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Safety and Feasibility of Epicardial Percutaneous Access and Maneuverability With a Novel Ablation Catheter for the Treatment of Atrial Fibrillation in a Porcine Model

Pre-Clinical
P Buszman, K Lukasik, S Deane et al
J Am Coll Cardiol 2021 (Supplement).

This was a first feasibility of epicardial access using the initial prototype of a next generation catheter system designed for sub-xiphoid access and with bipolar ablation capability. Access to the pericardial space was demonstrated with conventional needle technology and the catheter demonstrated promising tracking and navigation performance.

Electroporation of epicardial autonomic ganglia: Safety and efficacy in medium‐term canine models

Pre-Clinical
D Padmanabhan, N Naksuk, AK Killu et al
J Cardiovasc Electrophysiol 2019.

This study was performed using sub-xiphoid access with acute measurements showing that ganglionated plexi ablation produced an extension in the atrial effective refractory period (AERP). Extensive histology evaluations at four month follow-up demonstrated ablation of ganglia structures with sparing of the myocardium. The animals were resistant to AF induction at four months.

Novel Percutaneous Epicardial Autonomic Modulation in the Canine for Atrial Fibrillation: Results of an Efficacy and Safety Study

Pre-Clinical
M Madhavan, KL Venkatachalam, MJ Swale et al
Pacing Clin Electrophysiol 2016.

This was the first screening study at Mayo Clinic to assess the best energy source for ablation of ganglionated plexi, while minimizing myocardial damage. Following selection of pulsed field ablation (PFA) from the screening work, procedural feasibility was also demonstrated in both open-chest and sub-xiphoid models, using early prototype devices.