Argá Medtech Completes Enrollment of Paroxysmal AF Cohort in the COHERENT-AF Pivotal IDE Study

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Argá Medtech, a medical technology company developing sine wave-based pulsed field ablation (PFA) for cardiac arrhythmias, today announced the completion of enrollment in the paroxysmal atrial fibrillation (PAF) cohort of COHERENT-AF, its pivotal U.S. Investigational Device Exemption (IDE) study of the Coherent Sine Burst Electroporation (CSE) Platform.

Prospective, multicenter study evaluates the Coherent Sine Burst Electroporation Ablation Platform, a sine wave-based pulsed field ablation technology, in drug-refractory atrial fibrillation; persistent AF cohort enrollment continues

SAN DIEGO, Nov. 11, 2026 /PRNewswire/ -- Argá Medtech, a medical technology company developing sine wave-based pulsed field ablation (PFA) for cardiac arrhythmias, today announced the completion of enrollment in the paroxysmal atrial fibrillation (PAF) cohort of COHERENT-AF, its pivotal U.S. Investigational Device Exemption (IDE) study of the Coherent Sine Burst Electroporation (CSE) Platform. The PAF cohort enrolled 150 intention-to-treat subjects across 27 sites in Europe and the United States. Enrollment in the persistent AF (PersAF) cohort is ongoing and expected to complete in the next two months.

"Completing enrollment in the paroxysmal AF cohort is an important milestone for COHERENT-AF," said Emile Daoud, MD, Director of Electrophysiology Research; Hatton Research Institute at Bethesda North Hospital, Cincinnati, Ohio and the leading enroller in COHERENT-AF. "In our procedures, the CSE Platform has consistently delivered pulmonary vein isolation with a streamlined, single-catheter workflow, and the ability to address the pulmonary veins, posterior wall and cavo-tricuspid isthmus without exchanging catheters has been a meaningful advantage in our lab. We look forward to the completion of the persistent AF cohort and the 12-month effectiveness results."

COHERENT-AF (ClinicalTrials.gov: NCT06784466) is a prospective, multicenter, non-randomized pre-market study evaluating the safety and effectiveness of the CSE Platform in adults with symptomatic, drug-refractory PAF or PersAF. The study plan includes enrollment of up to 410 subjects in the United States and Europe, including 150 intention-to-treat subjects in each of the PAF and PersAF cohorts. Additional subjects will be enrolled in a second phase of the IDE investigation.

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