Argá Medtech Completes Enrollment of Paroxysmal AF Cohort in the COHERENT-AF Pivotal IDE Study
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.
All subjects undergo pulmonary vein isolation (PVI) with the CSE system. Posterior wall and other left atrial substrate and cavo-tricuspid isthmus ablation may be performed with the CSE system at the operator's discretion. Each cohort is evaluated separately against prespecified performance goals for safety and effectiveness, with subjects followed through 12 months.
"Reaching full enrollment so quickly in the paroxysmal AF cohort reflects the commitment of our investigators and study teams," said David Neale CEO, Argá Medtech. "We are now focused on completing the persistent AF cohort and generating the evidence needed to support FDA and CE-Mark regulatory submissions of the CSE Platform."
About the Coherent Sine Burst Electroporation Platform
The Argá Medtech CSE Platform features a single ablation catheter that can be configured by a simple stylet exchange to deliver circular, linear and focal ablation lesions. The CSE generator delivers controlled bursts of microsecond sine-waved based pulsed field ablation (PFA) across two, four or eight electrodes and can be titrated to treat the full spectrum of atrial tissue from thin-walled RV to thick septal or intramural circuits.
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
About Argá Medtech
Argá Medtech SA is a venture capital-backed medical technology company dedicated to developing and delivering innovative technology to help patients affected by heart rhythm disorders. Its PFA platform uses sine waves to deliver energy and includes the SineBurst™ Ablation Catheter and the SineWave™ Ablation Generator. The company is based at Biopôle Lausanne in Epalinges, Switzerland, with U.S. operations based in San Diego, California. Investors include Advent Life Sciences, Earlybird, Gilde Healthcare, High-Tech Gründerfonds and MedFocus. For more information, visit argamedtech.com.
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SOURCE Arga Medtech
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