AtriAN Medical has announced that it has completed enrolment of a second study using its selective pulsed field ablation (PFA) technology for the treatment of atrial fibrillation (AF).
The Neural AF-2 study has enrolled cardiothoracic surgery patients with paroxysmal AF, utilising AtriAN’s autonomic ablation technology to provide selective ablation of neuronal structures on the outside of the heart. A total of 12 patients were treated at Tbilisi Heart and Vascular Clinic (Tblisi, Georgia), with Tamaz Shaburishvili as the principal investigator. Patients will be followed out to one year for AF recurrence.
The new study builds on AtriAN’s initial Neural-AF study that focused on safety, feasibility and acute outcomes, in 24 patients undergoing concomitant coronary artery bypass grafting (CABG). The initial study was performed at Na Homolce Hospital in Prague (Czech Republic) and Tbilisi Heart and Vascular Clinic (Georgia). Data from that study was presented by Vivek Reddy MD (Mount Sinai Hospital, New York, USA) at the 2022 AF Symposium (January 13–15, New York, USA) and by Joris de Groot (Amsterdam UMC, Amsterdam, The Netherlands) at the European Heart Rhythm Association (EHRA) 2022 conference (3‒5 April, Copenhagen, Denmark).
The original Neural-AF study was an all-comers design for CABG patients that did not focus specifically on patients with AF. The findings indicate that selective epicardial PFA of ganglionated plexi is feasible and safe. An acute extension in atrial tissue refractoriness was also recorded; this is a well-recognised indicator of resistance to AF.
The AtriAN system includes catheters designed for use within the pericardial space and a generator for providing low energy pulsed electric fields. In the near future, the company plans to conduct clinical studies to assess delivery of the treatment using sub-xiphoid minimally invasive access.