Argá Medtech has completed enrolment in the Paroxysmal Atrial Fibrillation (PAF) cohort of COHERENT-AF, its pivotal US Investigational Device Exemption (IDE) study evaluating the safety and effectiveness of its Coherent Sine Burst Electroporation (CSE) Platform for treating cardiac arrhythmias.

The PAF cohort enrolled 150 intention-to-treat participants across 27 clinical sites in Europe and the United States. Enrolment in the persistent Atrial Fibrillation (PersAF) cohort is ongoing and is expected to be completed within the next two months.

COHERENT-AF is a prospective, multicentre, non-randomised pre-market study involving adults with symptomatic, drug-refractory PAF or PersAF. The study is planned to enrol up to 410 participants across the United States and Europe. This includes 150 intention-to-treat participants in each of the PAF and PersAF cohorts, with additional participants to be enrolled during a second phase of the IDE investigation.

All participants undergo Pulmonary Vein Isolation (PVI) using the CSE system. At the treating physician's discretion, the system may also be used for posterior wall and other left atrial substrate ablation, as well as cavo-tricuspid isthmus ablation. Each cohort is assessed separately against predefined safety and effectiveness performance goals, with participants followed for 12 months.

Commenting on the enrolment milestone, Emile Daoud, MD, Director of Electrophysiology Research at the Hatton Research Institute, Bethesda North Hospital, Cincinnati, Ohio, and the leading enroller in the study, said the platform had enabled pulmonary vein isolation through a single-catheter workflow in procedures. He also highlighted its ability to address the pulmonary veins, posterior wall and cavo-tricuspid isthmus without requiring catheter exchanges. He said the investigators were looking forward to completing the PersAF cohort and evaluating the 12-month effectiveness results.

David Neale, CEO of Argá Medtech, said the completion of enrolment in the PAF cohort reflected the efforts of the investigators and study teams. The company is now focusing on completing the PersAF cohort and generating clinical evidence to support regulatory submissions to the US Food and Drug Administration (FDA) and the European CE marking process.

The CSE Platform comprises a single ablation catheter that can be configured through a stylet exchange to deliver circular, linear and focal ablation lesions. Its generator delivers controlled microsecond sine-wave-based Pulsed Field Ablation (PFA) energy across two, four or eight electrodes. The energy can be adjusted to address different types of atrial tissue, including thin-walled and thicker septal or intramural tissue.