Johnson & Johnson MedTech has concluded subject enrolment for the pilot phase of the OMNY-AF study of the investigational OMNYPULSE Platform for treating symptomatic paroxysmal atrial fibrillation (AFib) in Australia and the US.
The prospective, single-arm, multi-centre OMNY-AF study has now enrolled 30 patients in its pilot phase.
It 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).
Johnson & Johnson MedTech cardiovascular and specialty solutions scientific affairs vice-president Jennifer Currin said: “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.
“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.”
The 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.
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.
Earlier this year, enrolment 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.
