Argá Medtech Completes Key Atrial Fibrillation Trial Milestone

San Diego, California, USA, November 12, 2026

COHERENT-AF Study Reaches PAF Enrollment Milestone

The COHERENT-AF study is a prospective, multicenter, non-randomized pre-market clinical investigation designed to assess the safety and effectiveness of the CSE Platform in adults with symptomatic, drug-refractory paroxysmal or persistent atrial fibrillation. The study is being conducted under a U.S. IDE framework and is intended to generate clinical evidence to support potential regulatory submissions. According to Argá Medtech, the completed PAF cohort enrolled 150 intention-to-treat participants at 27 sites across Europe and the United States. The persistent atrial fibrillation (PersAF) cohort is still recruiting, with enrollment expected to be completed within approximately two months of the announcement. The overall study plan includes up to 410 participants across the United States and Europe, with 150 intention-to-treat participants planned in each of the PAF and PersAF cohorts, alongside additional participants in a second phase of the IDE investigation. Each cohort will be evaluated separately against predefined safety and effectiveness performance goals. Participants will be followed for up to 12 months, allowing investigators to assess outcomes after the ablation procedure.

CSE Platform Uses Sine Wave-Based Pulsed Field Ablation

The CSE Platform is designed to deliver pulsed field ablation energy using controlled bursts of microsecond sine waves. Its system includes an ablation catheter and generator intended to support different lesion configurations through a single-catheter workflow. The catheter can be configured through a stylet exchange to deliver circular, linear and focal ablation lesions. The generator can deliver energy across two, four or eight electrodes, with treatment settings adjustable for different types of atrial tissue. In the COHERENT-AF study, all participants undergo pulmonary vein isolation (PVI) using the CSE system. This procedure targets electrical pathways around the pulmonary veins, which are commonly involved in triggering atrial fibrillation. At the treating physician’s discretion, the system may also be used for ablation of the posterior wall and other left atrial tissue, as well as the cavo-tricuspid isthmus. These additional treatment options are being evaluated within the study protocol. The platform’s single-catheter approach is intended to support multiple ablation patterns without requiring catheter exchanges during different parts of the procedure. However, its clinical performance and safety must be established through the ongoing investigation and subsequent regulatory review.

Persistent AF Enrollment and Regulatory Evidence Remain Priorities

Commenting on the enrollment milestone, Emile Daoud, MD, Director of Electrophysiology Research at the Hatton Research Institute, Bethesda North Hospital, and the leading enroller in COHERENT-AF, described the completed PAF enrollment as an important achievement for the study. He highlighted the platform’s single-catheter workflow and its ability to address multiple cardiac regions during procedures. He also expressed interest in completing the persistent AF cohort and obtaining the 12-month effectiveness results. David Neale, Chief Executive Officer of Argá Medtech, said the company is now focused on completing enrollment in the PersAF cohort and generating the clinical evidence required to support future FDA and CE Mark regulatory submissions. The results from the study will be important in determining whether the technology can meet the required safety and effectiveness expectations for its intended use. Atrial fibrillation is a common heart rhythm disorder in which irregular electrical activity causes the heart’s upper chambers to beat irregularly. Paroxysmal AF episodes begin and stop intermittently, while persistent AF lasts longer and may require more sustained treatment. For patients whose symptoms continue despite medication, catheter-based ablation may be considered as a treatment option. The COHERENT-AF investigation is therefore intended to evaluate a potential technology for this clinical setting. The study is registered as NCT06784466. Importantly, Argá Medtech states that the CSE Platform remains an investigational device and is limited by U.S. law to investigational use. Completion of enrollment in one cohort does not establish clinical effectiveness or indicate regulatory approval. Further follow-up, analysis and regulatory review will be necessary before any conclusions can be drawn about its future clinical use.

Source: Argá Medtech press release