Field Medical has announced the presentation of late-breaking clinical trial data from the first-in-human Field PULSE study—which is evaluating the company’s FieldForce ablation system and catheter—at the 2026 AF symposium (5–7 February, Boston, USA).
Field PULSE is assessing a novel high-voltage, sub-second pulsed field waveform delivered through the FieldForce ablation system and catheter, which is described by the company as a focal, contact-sensing catheter enabling instantaneous ablation through point-by-point energy delivery without reliance on prolonged tissue-catheter contact.
“By eliminating the need for sustained tissue-catheter contact, sub-second pulsed field delivery enables both efficient point-by-point ablation and individualised lesion sets,” said Field PULSE principal investigator Vivek Reddy (Mount Sinai, New York, USA). “This approach preserves the flexibility physicians expect from focal ablation while delivering the procedural efficiency associated with pulsed field technologies.”
Data from the Field PULSE study revealed “instantaneous energy delivery”, with lesions being created in less than 200 milliseconds, enabling rapid point-by-point ablation, as well as procedural efficiency indicated by a median bilateral pulmonary vein isolation (PVI) time of 12.5 minutes—with the fastest case being completed in 7.7 minutes.
Field Medical also highlights the fact that remapping within the trial demonstrated progressive improvements in PVI durability of 94.2% by vein, and 84.6% by patient, with the optimised waveform. In terms of safety outcomes, there were no device-related serious adverse events; no acute kidney injury, reported phrenic nerve palsy or clinically relevant haemolysis; and no silent cerebral lesions observed among a total of 14 patients evaluated via brain magnetic resonance imaging (MRI).
The company claims in a press release that these findings extend the body of clinical evidence on its high-voltage focal pulsed field ablation (PFA) approach beyond ventricular arrhythmias and into the development of therapy for atrial fibrillation (AF). Together with previously reported six-month first-in-human ventricular tachycardia (VT) data, the results support the emergence of a versatile ablation platform for all chambers of the heart, designed to enable focal PFA across atrial and ventricular substrates while preserving procedural efficiency, the release adds.
“The Field PULSE results reinforce our approach of deliberately architecting focal PFA to address the fundamental limitations of existing methods, then validating its application through data,” said Steven Mickelsen, founder and chief technology officer of Field Medical. “By delivering each ablation point in a fraction of a second, we reduce dependence on prolonged catheter stability, limit the impact of cardiac motion, and establish a platform approach for treating complex arrhythmias.”
