Atrial fibrillation (AF), the most common cardiac arrhythmia, affects nearly 38 million people worldwide and continues to drive demand for safer, faster, and more effective treatment options. Pulsed field ablation (PFA) has emerged as a breakthrough alternative to traditional thermal methods, offering efficiency and improved safety without compromising outcomes. At the forefront of this innovation is Argá Medtech, developer of the Coherent Sine-Burst Electroporation™ (CSE™) System—a next-generation PFA platform designed to expand treatment possibilities while simplifying workflows for physicians.
In this exclusive interview, David Neale, CEO and Founder of Argá Medtech, discusses the company’s pivotal COHERENT-AF trial, the unique advantages of sinusoidal wave-based ablation, and how the CSE platform’s multi-configurable catheter design could redefine standards of care in AF treatment. He also shares Argá’s vision for expanding applications beyond pulmonary vein isolation and its roadmap toward global regulatory approvals.
Argá Medtech has initiated the COHERENT-AF pivotal trial for its CSE™ System. Could you share the key objectives of this study and how it builds on the promising outcomes of the BURST-AF clinical study?
BURST- AF, our feasibility study, has enrolled just over 100 patients with excellent results, with 6-month freedom from Paroxysmal AF of 96.4% and Persistent AF of 91.4%. COHERENT-AF is the pivotal study to evaluate the safety and effectiveness in a larger sample of Paroxysmal and Persistent AF patients.
The key outcome measures for COHERENT-AF include:
Evaluating up to 360 study participants that may experience a primary safety event within 7 days, 30 days and 180 days.
Evaluating the combined effectiveness of treatment at the end of the procedure and through 12 months. The effectiveness endpoint includes freedom from ≥ 30 seconds of AF, AFL, AT on an in-hospital or patient-reported remote ECG or Holter Monitor after a 90-day blanking period, re-ablation, electrical cardioversion or increased dosage of antiarrhythmic drugs (Class I or Class III).
The study will also collect other important procedural and follow-up data with a goal to demonstrate important productivity, quality-of-life and economic impact.
Your CSE™ platform uses sinusoidal wave-based pulsed field ablation compared to square-wave systems. How does this technical difference translate into clinical advantages for physicians and patients?
Using a sine wave for the basis of the pulsed field ablation waveform provides the following advantages:
Flexible energy delivery – including delivery of either bipolar or combination bipolar/unipolar energy. Bipolar energy delivery fills the gaps between electrodes during multi-electrode delivery and in combination with unipolar energy delivery allows titration of lesion depth.
Transformer coupling is compatible – transformer coupling is the gold standard for providing electrical isolation for patient safety.
Efficient therapeutic delivery – including lower power to deliver the required voltage, lower thermal component for lesion depth and less emissions during therapy.
The flexibility of the CSE catheter, which allows circular, linear, and focal ablations without catheter exchanges, seems to be a major differentiator. What efficiencies or safety improvements have early adopters reported from this design?
Current ablation tools are mostly divided into “single-shot” devices for isolation of the pulmonary veins, and focal catheters that rely on the ability of the operator to produce continuous lines by delivering overlapping lesions. The Argá stylet-driven, multi-configurable catheter offers a simpler solution. The circular configuration is as easy-to-use as “single shot” devices for pulmonary vein isolation. It can efficiently be reconfigured into a multi-electrode linear configuration to produce contiguous lines that reduce the risk of gaps when focal lesions are not properly overlapped.
Physicians have noted that the ability to change shapes without catheter exchanges provides an added layer of safety to the procedure by avoiding exchanges and reducing the opportunity for air ingress, which could lead to an adverse event.
The single catheter helps to reduce procedure costs, eliminating the need for additional mapping and ablation catheters for procedures requiring lesion sets beyond pulmonary vein isolation.
The variety of shapes and multi-electrode configurations allows adaptation to each area requiring ablation and provides efficiencies in creating lines and encircling the pulmonary veins.
With AF affecting nearly 38 million people worldwide, what role do you see PFA, and specifically your CSE technology, playing in making ablation a safer and more scalable treatment option globally?
The speed, efficiency, and effectiveness of PFA platforms have changed the landscape of AF ablation, allowing for optimized workflows, increased procedural efficiency, safety improvements, all without compromise to outcomes.
The flexibility of the system and usage options make CSE technology ideal for use by any trained operator.
Elimination of catheter exchanges helps to reduce the opportunity for air ingress, increasing procedure safety.
The single catheter system may provide economic value to the hospital system and reduce total healthcare costs in general by improving procedural safety and effectiveness.
Ability to use the CSE system without mapping requires less equipment, personnel and flexibility in scheduling procedure rooms.
Beyond pulmonary vein isolation, how does the CSE system expand the scope of treatment for persistent AF patients, and what clinical gaps does it address compared to traditional thermal ablation methods?
We believe the CSE method can make anatomic strategies for treating persistent AF easier and safer than traditional thermal methods. Radiofrequency (RF) methods rely on the operator’s ability to overlap as many as 100 focal lesions to achieve pulmonary vein isolation and linear block. The Argá CSE system allows direct creation of linear and focal lesions, when required, delivering procedural efficiency and reducing the possibility of gaps that may lead to recurrence.
Looking ahead, what are Argá Medtech’s next milestones—both in terms of clinical development and potential regulatory approvals—that we can expect following the COHERENT-AF trial?
Argá Medtech intends to seek regulatory approvals for the CSE system to treat atrial fibrillation beyond US FDA approval. Study enrollment should be completed in less than 12 months with FDA and CE marking regulatory submissions occurring soon after.
Investigating use of the system to treat ventricular arrhythmias – an area that is currently underserved by thermal ablation systems and remains the next frontier of cardiac treatment therapy.
