The paroxysmal atrial fibrillation cohort in Argá Medtech’s COHERENT-AF study has enrolled 150 intention-to-treat subjects at 27 sites in Europe and the United States. The company said enrollment in the persistent AF cohort is continuing and is expected to finish within two months.
The prospective, multicenter U.S. Investigational Device Exemption study is evaluating the safety and effectiveness of Argá’s Coherent Sine Burst Electroporation (CSE) Platform in adults with symptomatic, drug-refractory paroxysmal or persistent atrial fibrillation. The non-randomized study plans to enroll up to 410 people in the United States and Europe, with 150 intention-to-treat subjects in each of the two cohorts. Additional subjects will join a second phase of the IDE investigation.
All participants undergo pulmonary vein isolation using the CSE system. Operators may also use it for posterior wall and other left atrial substrate ablation, as well as cavo-tricuspid isthmus ablation. Each cohort is assessed separately against prespecified safety and effectiveness goals, with follow-up through 12 months.
Emile Daoud, director of electrophysiology research at the Hatton Research Institute, Bethesda North Hospital, in Cincinnati, Ohio, and the study’s leading enroller, called the completed enrollment an important milestone. He said the platform had consistently delivered pulmonary vein isolation in his procedures using a single-catheter workflow, and that treating the pulmonary veins, posterior wall and cavo-tricuspid isthmus without changing catheters had been an advantage. He said he looked forward to completion of the persistent AF cohort and 12-month effectiveness results.
Argá CEO David Neale said the company is now focused on finishing enrollment in that cohort and generating evidence for FDA and CE-Mark regulatory submissions. COHERENT-AF is registered as NCT06784466. The CSE Platform remains an investigational device, limited by U.S. law to investigational use.
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