Biotronik has announced the enrolment of the first patient in the RESET-AF 3D study, a multicentre clinical study evaluating the Elepulse pulsed field ablation (PFA) system for its performance in the treatment of atrial fibrillation (AF) patients. The study aims to support CE-mark approval for the Elepulse PFA system, which introduces a single-shot, single-position approach to pulmonary vein isolation (PVI).
The first procedure on a patient as part of the study was performed at Na Homolce Hospital in Prague, Czechia by Vivek Reddy (Mount Sinai Health System, New York, USA).
“The procedure using the new Elepulse PFA system was efficient,” Reddy said. “Its single-shot, single-position design performed well and has real potential to simplify AF ablation workflows.”
Petr Neužil (Na Homolce Hospital, Prague, Czechia) added: “We are proud to enrol the first patient in the study here at Na Homolce Hospital. As a centre committed to research, we are excited to help validate a promising next-generation PFA technology.”
According to Biotronik, the Elepulse PFA system combines a 3D spiral multi-electrode catheter with a compact PFA generator. It delivers ‘donut-shaped’ pulsed fields for durable, transmural PVI and contiguous ring-shaped ablations beyond the veins—all without catheter repositioning. The system integrates “seamlessly” with standard 8.5Fr sheaths and widely used 3D mapping platforms, minimising workflow disruption, and reducing setup complexity and training needs, the company also claims in a press release.
In a first-in-human cohort of 36 patients, Elepulse achieved 100% acute PVI, 92% freedom from AF at 12 months, and no thermal-related complications, the release adds.
“Elepulse provided true single-shot ablations that were fast, effective and well-tolerated by patients,” noted principal investigator Petr Peichl (Institute for Clinical and Experimental Medicine [IKEM], Prague, Czechia). “This study will help us evaluate the system’s ability to deliver durable AF treatment without catheter repositioning, greatly contributing to streamlining workflows.”
“RESET-AF 3D reflects our commitment to advancing cardiac electrophysiology through meaningful innovation,” added Andreas Hecker, president of cardiac rhythm management (CRM)/electrophysiology (EP) at Biotronik. “Elepulse represents a major step forward in establishing PFA as a transformative technology in AF with simpler, faster, safer treatment for patients.”
Biotronik states that the RESET-AF 3D study “lays the foundation” for the CE-mark approval and market release of Elepulse, reinforcing the company’s commitment to delivering value-adding, patient-centric solutions.
