Argá Medtech, developers of the Coherent Sine-Burst Electroporation (CSE) System, a next-generation pulsed field ablation (PFA) system for treating cardiac arrhythmias, including atrial fibrillation (AF), announced initial enrollments in the COHERENT-AF clinical trial. COHERENT-AF, a U. S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial, is a prospective, non-randomised trial designed to evaluate the safety and effectiveness of the CSE System in patients with paroxysmal and persistent atrial fibrillation (AF). The COHERENT-AF trial will enrol up to 360 patients across clinical sites in the United States and Europe.

The first patients were treated by Dr Ante Anic at KBC Split Hospital, Split, Croatia. Post-procedure, all patients were doing well and have subsequently been released from the hospital to continue their recovery. Following the procedures, Dr. Anic noted that "The flexibility of the CSE platform fills a gap when treating patients beyond pulmonary vein isolation. The single, stylet-driven, multi-configurable ablation catheter easily transitions to deliver linear and focal ablations, providing procedural efficiencies when treating both paroxysmal and persistent AF patients and adds a layer of safety by eliminating catheter exchanges."

The CSE system has been used to date in over 100 patients, demonstrating greater than 94 per cent lesion durability at 3 months, 92.6 per cent freedom from atrial arrhythmias at 6 months and a 1.0 per cent adverse event rate in Arga Medtech's initial BURST-AF clinical study.1 "Initiation of COHERENT-AF is a major milestone for Arga Medtech," said David Neale, CEO of Argá Medtech. "It marks the start of our journey to bring a next-generation, safe, fast, and effective ablation treatment to the millions of people affected by cardiac rhythm disorders and atrial fibrillation."