Australia joins trial of new pulsed field ablation technology for atrial fibrillation

Atrial fibrillation (AF), the most common type of cardiac arrhythmia, is witnessing a paradigm shift in treatment approaches with the evolution of pulsed field ablation (PFA). While Boston Scientific and Medtronic have led the market, Johnson & Johnson MedTech is now advancing its position with the completion of patient enrolment in the pilot phase of the OMNY-AF clinical trial, which includes participants from Australia.

“The evidence is mounting that early and aggressive intervention, especially in the younger cohort, gives better outcomes. The evolution of a new energy source when it comes to atrial fibrillation ablation – pulsed field ablation (PFA) – is also a therapeutic game changer,” said A/Professor Chrishan Nalliah, Electrophysiologist at MQ Health, in a recent interview with Health Industry Hub.

Unlike traditional ablation methods that utilise radiofrequency or cryothermal energy, PFA employs pulsed electric fields to induce irreversible electroporation, selectively targeting arrhythmic tissue with greater precision and reduced complications.

The OMNY-AF clinical trial is evaluating the Omnypulse platform for treating symptomatic paroxysmal AFib in Australia and the U.S. The single-arm, multi-centre trial has successfully enrolled 30 patients in its pilot phase, with plans to recruit up to 410 additional participants in the pivotal phase. The trial includes a 12-month follow-up period, aiming for completion by May 2026. Australian recruitment sites include Royal Adelaide Hospital and Canberra Heart Rhythm.

“There are many patients that don’t have symptoms, and so sometimes it’s not until they have a stroke that it’s diagnosed. The other challenge is access to treatment. In some public hospitals, we have 1-2 year waiting lists for catheter ablation,” said Tanya Hall, CEO of hearts4heart, highlighting the urgency of advancing AF treatment solutions.

The Omnypulse platform includes the Omnypulse catheter, a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref reference electrode, and the Trupulse Generator, which provides bipolar, biphasic pulse applications. Together with the Carto 3 – 3D heart mapping system – the platform allows clinicians to calculate a Pulsed Field Index value, facilitating precision in ablation procedures.

“The OMNY-AF study is part of our ongoing efforts to equip electrophysiologists with the tools they need to efficiently and effectively conduct ablation procedures to drive positive outcomes for patients with AFib,” said Jennifer Currin, Vice President, Scientific Affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech.

“The ability to make personalised treatment decisions with the help of an integrated solution that allows electrophysiologists to both evaluate and treat would bring tremendous value to doctors and patients.”

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