Argá Medtech Completes Paroxysmal AF Cohort Enrollment in COHERENT-AF Study
News related to:Argá Medtech · 1 min read
SAN DIEGO, Nov. 11, 2026 /CourierPR/ -- Argá Medtech, a Swiss medical technology company, has completed the enrollment of the paroxysmal atrial fibrillation (PAF) cohort in its COHERENT-AF pivotal U.S. Investigational Device Exemption (IDE) study. The study, which evaluates the safety and effectiveness of the Coherent Sine Burst Electroporation (CSE) Platform, a sine wave-based pulsed field ablation technology, has enrolled 150 intention-to-treat subjects across 27 sites in Europe and the United States.
The CSE Platform, developed by Argá Medtech, features a single ablation catheter that can deliver circular, linear, and focal ablation lesions. The platform uses controlled bursts of microsecond sine-wave-based pulsed field ablation (PFA) across two, four, or eight electrodes, making it adaptable to various types of atrial tissue. The study, which is registered on ClinicalTrials.gov under the identifier NCT06784466, is part of a prospective, multicenter, non-randomized pre-market evaluation of the CSE Platform in adults with symptomatic, drug-refractory PAF or persistent atrial fibrillation (PersAF).
In the PAF cohort, subjects undergo pulmonary vein isolation (PVI) with the CSE system. Additional ablation procedures, such as posterior wall and other left atrial substrate and cavo-tricuspid isthmus ablation, may be performed at the operator's discretion. Each cohort will be evaluated separately against prespecified performance goals for safety and effectiveness, with subjects followed through 12 months.
Dr. Emile Daoud, Director of Electrophysiology Research at the Hatton Research Institute at Bethesda North Hospital in Cincinnati, Ohio, and a leading enroller in COHERENT-AF, highlighted the advantages of the CSE Platform.
Argá Medtech's CEO, David Neale, expressed satisfaction with the progress of the study.
The COHERENT-AF study aims to enroll up to 410 subjects in the United States and Europe, with the persistent AF cohort expected to complete enrollment in the next two months. The company is based at Biopôle Lausanne in Epalinges, Switzerland, with U.S. operations in San Diego, California. Investors in the company include Advent Life Sciences, Earlybird, Gilde Healthcare, High-Tech Gründerfonds, and MedFocus.