Johnson & Johnson MedTech has concluded subject enrollment for the pilot phase of the OMNY-AF study, which is evaluating the investigational OMNYPULSE Platform for the treatment of symptomatic paroxysmal atrial fibrillation (AFib). The trial, conducted across sites in Australia and the US, marks a significant step in the development of new tools for electrophysiologists to conduct ablation procedures more effectively.
The prospective, single-arm, multi-center OMNY-AF study has enrolled 30 patients in its pilot phase. The study aims to recruit up to 410 additional patients for its pivotal phase across both countries. The primary goal is to demonstrate the 12-month effectiveness and safety of the OMNYPULSE Platform for pulmonary vein isolation to treat symptomatic paroxysmal AFib.
The next phase will commence following a review of acute safety data from the pilot group by the US Food and Drug Administration (FDA).
OMNYPULSE Platform Details
The OMNYPULSE Platform comprises the OMNYPULSE Catheter and TRUPULSE Generator. It is designed to facilitate AFib treatment strategies using Pulsed Field Ablation (PFA) therapy combined with mapping through the CARTO 3 System, a 3D heart mapping system. The investigational large-tip, 12mm focal catheter comes with contact force sensing, and a TRUEref reference electrode to mitigate far-field unipolar signals’ impact. The TRUPULSE Generator delivers bipolar, biphasic pulse applications to the 12 electrodes of the catheter.
Clinicians can use the CARTO 3 System to obtain a pulsed field index value, which is calculated using real-time contact force feedback and the number of pulsed-field applications. This index serves as an ablation target for specific locations within the heart.
Integrated Solution for Personalized Treatment
Jennifer Currin, Vice President of Scientific Affairs, Cardiovascular and Specialty Solutions at Johnson & Johnson MedTech, stated that the OMNY-AF study is part of their ongoing efforts to equip electrophysiologists with the tools needed to efficiently and effectively conduct ablation procedures to drive positive outcomes for patients with AFib. She emphasized the value of an integrated solution that allows electrophysiologists to both evaluate and treat, enabling personalized treatment decisions.
Prior Trials and Future Availability
Earlier this year, enrollment was completed for the Omny-IRE clinical trial, evaluating the same platform in Europe and Canada. Currently under development, the OMNYPULSE Platform is not yet available for sale anywhere in the world.
