First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation

Swiss company Argá Medtech has begun enrollment in a First-in-Human Clinical Trial of its CSE Ablation System in the treatment of atrial fibrillation (AFib). The study, titled “Coherent Sine Burst Electroporation (CSE) System Pilot Study in Patients with Atrial Fibrillation (BURST-AF)” is designed to test the acute safety and efficiency of the system. The first five patients, four with paroxysmal and one with persistent AFib, were successfully treated by Dr. Giorgi Papiashvili with support from Dr. Ante Anic, at the Healthycore Medical Center in Tbilisi, Georgia.


AFib is the most common heart arrhythmia affecting over 33 million patients worldwide and makes them 5 times more likely to have a stroke. Patients with AFib have a significantly poorer quality of life when compared to healthy individuals, experiencing a variety of symptoms including lethargy, palpitations, dyspnea, chest tightness, sleeping difficulties, and psychosocial distress. Ablation using thermal energy (radiofrequency or cryogenic) has proven to be an effective treatment in alleviating AFib associated symptoms and improving quality-of-life. However, there are risks associated with the use of thermal energy that include the potential to damage critical structures such as the esophagus or nerves that surround the heart. Pulsed field ablation energy delivery is tissue selective, ablating the selected heart tissue, while sparing nearby tissues.

The CSE system consists of a configurable (circular, linear, and focal) ablation catheter and pulsed field ablation (PFA) generator. In contrast to all other PFA waveforms, CSE employs a unique sinusoidal wave instead of a square wave. CSE is designed to minimize muscle stimulation, decrease bubble formation, and increase targeted energy delivery to create transmural lesions in tissue of any thickness. CSE offers unmatched flexibility to deliver bipolar, unipolar, or a combination of both waveforms that enables the user to titrate the width and depth of the ablation lesion.

Company comments

“We are very pleased with the performance of our CSE System in this initial group of patients,” stated David Neale, CEO of Argá Medtech. “The ability to deliver three different lesion sets with a single catheter, combined with a generator that titrates lesion depth and width, enables electrophysiologists to safely and efficiently treat any location in the heart.”

Clinician comments

The physicians and lab staff were excited to provide this new therapy option to their AFib patients. “It was easy to change the ablation catheter from circular to linear,” said Dr. Papiashvili, “and not having to exchange catheters for each lesion set is a game changer.” Visiting physician Dr. Ante Anic (University Hospital Split, Croatia) added, “Energy delivery was very impressive, with no muscle stimulation, no bubbles and very adaptable to the patient’s needs. The catheter flexibility allowed the pulmonary veins to be quickly isolated using the circular configuration and then easily changed to deliver a ‘linear single-shot’ roof line.”

Source: Argá Medtech

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