Argá Medtech Finalizes Enrollment for Paroxysmal AF Cohort in Pivotal COHERENT-AF Study

Argá Medtech Completes Enrollment in Paroxysmal Atrial Fibrillation Cohort

On November 11, 2026, Argá Medtech, a pioneering company in medical technology, proudly announced the successful completion of participant enrollment for the paroxysmal atrial fibrillation (PAF) cohort within the framework of its groundbreaking COHERENT-AF study. This pivotal clinical trial focuses on the use of the Coherent Sine Burst Electroporation (CSE) Platform, an innovative technology developed for the treatment of cardiac arrhythmias, specifically targeting those who do not respond to traditional drug therapies.

The enrollment for the PAF cohort saw an impressive intake of 150 participants, gathered from 27 medical sites located across both the United States and Europe. Importantly, while the PAF cohort has been fully enrolled, the recruitment for the persistent atrial fibrillation (PersAF) cohort is still ongoing, with expectations set to complete this phase within the next two months.

Dr. Emile Daoud, the Director of Electrophysiology Research from the Hatton Research Institute at Bethesda North Hospital in Cincinnati, Ohio, and the leading enroller in the study, expressed significant enthusiasm over this enrollment milestone. He noted, "Completing enrollment in the paroxysmal AF cohort is an important milestone for COHERENT-AF. Our procedures utilizing the CSE Platform have consistently provided effective pulmonary vein isolation, benefiting from a streamlined, single-catheter workflow. The ability to address various heart structures without the need for catheter exchanges has proven to be a substantial advantage in our operations. We are eager to wrap up the persistent AF cohort and to analyze the effectiveness results over the next 12 months."

Overview of the COHERENT-AF Study

COHERENT-AF, registered under ClinicalTrials.gov (NCT06784466), is a prospective, multicenter, non-randomized pre-market investigation aimed at evaluating the safety and effectiveness of the CSE Platform. This study targets adults suffering from symptomatic, drug-refractory PAF or PersAF. The broader study design foresees the eventual inclusion of up to 410 subjects across the U.S. and Europe, with equal representation from both the PAF and PersAF cohorts. Furthermore, as the study advances, more participants are anticipated to join in a subsequent phase of the Investigational Device Exemption (IDE) investigation.

As part of the study protocol, all subjects will undergo pulmonary vein isolation (PVI) using the CSE system, with the option for further ablation procedures depending on individual operator discretion. Each cohort will be analyzed against established performance goals related to safety and effectiveness, with participants followed and assessed over a 12-month period.

Future Directions and Innovations

David Neale, CEO of Argá Medtech, remarked on the swift completion of enrollment for the PAF cohort, attributing it to the dedication of the investigators and study teams involved. He stated, "Reaching full enrollment so quickly in the paroxysmal AF cohort reflects the commitment of our investigators and study teams. We are now focused on completing the persistent AF cohort and generating the evidence required to support our FDA and CE-Mark regulatory submissions for the CSE Platform."

About the CSE Platform

The Argá Medtech CSE Platform is designed to enhance the treatment options for patients with atrial fibrillation. It features a single ablation catheter capable of being adjusted by a simple stylet exchange to facilitate circular, linear, and focal ablation lesions. The CSE generator administers controlled bursts of microsecond sine wave-based pulsed field ablation (PFA) across two, four, or eight electrodes, allowing it to treat a wide range of atrial tissue types from various cellular thicknesses.

Company Background

Argá Medtech SA operates as a venture capital-backed enterprise with a mission to innovate within the medical technology field, particularly for patients plagued by heart rhythm disorders. The foundation of its PFA platform is its unique sine wave technology, which powers their SineBurst™ Ablation Catheter and SineWave™ Ablation Generator. Founded in Biopôle, Lausanne, Switzerland, with operations in the vibrant city of San Diego, California, Argá Medtech is backed by several investors, including Advent Life Sciences and High-Tech Gründerfonds. For more details on their cutting-edge work, visit their official website at argamedtech.com.