Argá Medtech has announced positive clinical results from the BURST-AF first-in-human trial, demonstrating the safety, effectiveness, and durability of its Coherent Sine-Burst Electroporation (CSE) System for the treatment of paroxysmal and persistent atrial fibrillation (AF).
Data presented at AF Symposium 2026 (Boston, February 5–7) showed 94 per cent overall lesion durability, 100 per cent procedural success, and an excellent safety profile using a single, stylet-driven, multi-configurable catheter.
AF is the most common heart arrhythmia, affecting about 38 million patients worldwide, and it makes them five times more likely to have a stroke than people without AF.
“While pulsed field ablation has transformed AF treatment, many systems report low durability for the complex lesion sets beyond pulmonary vein isolation,” said Ante Anic, MD, Head of the Electrophysiology Lab at KBC Split Hospital and BURST-AF investigator.
“In this study, the CSE System enabled efficient, single-catheter ablation across multiple lesion sets with high durability, short ablation times of 20 minutes for pulmonary vein isolation, and an additional 15 minutes for additional linear ablations.
“These data support sine-burst electroporation as an important next step in AF ablation.”
Argá Medtech’s CSE PFA platform utilises a proprietary CSE PFA generator and a multi-configurable catheter to enable unmatched flexibility in the treatment of AF.
The system’s sinusoidal/sine wave allows energy delivery to be tailored to the different depths of tissue targeted for ablation.
The unique waveform is delivered using a single, all-in-one catheter with a form factor that can be shaped to create circular, linear, or focal ablation lesions.
This eliminates the need for catheter exchanges, reducing the risk of introducing air bubbles as one catheter is removed and another is reinserted. It can also reduce procedural time and costs.
BURST-AF enrolled 101 patients with drug-refractory paroxysmal (59 per cent) or persistent (41 per cent) AF at four clinical sites. Patients underwent cardiac ablation with the CSE System, including pulmonary vein isolation (PVI), posterior wall isolation (PWI), and cavo-tricuspid isthmus (CTI) ablation.
Patients were re-mapped at 60-90 days post ablation and also were assessed at 6 and 12 months post procedure. Key study findings include:
- 100 per cent procedural success in both paroxysmal and persistent AF.
- PVI durability of 97.4 per cent and 91.7 per cent in paroxysmal and persistent AF, respectively, at 60-90-day remapping.
- CTI durability of 100 per cent and 97.4 per cent in paroxysmal and persistent AF, respectively, at 60-90-day remapping.
- In patients with persistent AF, inferior and superior PWI durability was 92.1 per cent and 84.2 per cent, respectively.
- At 6-month follow up, 56 of 58 (96.6 per cent) of paroxysmal and 35 of 38 (92.1 per cent) of persistent AF patients were free of AF, atrial flutter (AFL), and atrial tachycardia (AT) with or without anti-arrhythmic drugs (AAD).
- At 12-month follow up: 50 of 55 (90.9 per cent) of paroxysmal and 28 of 34 (82.4 per cent) of persistent AF patients were free of AF, AFL, AT off AAD.
Safety results show no pulmonary vein stenosis, silent cerebral events (SCE)/silent cerebral lesions (SCL), clinically apparent coronary spasm, phrenic nerve damage/paralysis, esophageal damage, or conduction disorders.
“These findings validate the clinical and procedural benefits of our CSE System and further increase our confidence that the ongoing U.S. IDE study will achieve its endpoints,” said David Neale, co-founder and Chief Executive Officer at Argá Medtech.
“Our ability to reach 50 per cent enrollment in the IDE study in only 4 months underscores the high interest in our unique PFA solution and its potential benefits among the interventional electrophysiology community.
“We are committed to generating a robust body of data that will support regulatory and an eventual PMA submission for FDA approval of the CSE™ System.”
During the meeting, Argá Medtech also announced that its COHERENT-AF (NCT06784466) IDE clinical trial has reached 50 per cent enrolment.
The prospective, non-randomized, trial is designed to evaluate the safety and effectiveness of the CSE System in patients with paroxysmal and persistent AF.
Up to 360 patients across clinical sites in the United States and Europe will be enrolled.
