The OMNY-AF clinical trial evaluates the investigational platform for the treatment of symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase enrollment of 30 patients. Johnson & Johnson expects to enroll up to an additional 410 patients in the pivotal phase.
Irvine, California-based J&J’s trial has a primary objective of demonstrating the safety and 12-month effectiveness of Omnypulse for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal AFib. The company expects the pivotal phase to begin once the FDA completes a review of acute safety data from the pilot group.
Omnypulse platform features the Omnypulse catheter and the Trupulse generator. The company offers the catheter as a large-tip, 12 mm device with Carto 3 system integration. It features contact force feedback and enhanced mapping capabilities. Altogether, it combines pulsed field ablation (PFA) therapy and mapping.
The investigational Trupulse generator delivers a bipolar, biphasic pulse sequence to the catheter’s 12 electrodes during cardiac ablation. It features contact force sensing and the Trueref reference electrode, reducing the impact of far-field unipolar signals. J&J said it designed the platform to enable AFib strategies with a single device. It combines a large ablation area with the ability to create high-density maps.
Earlier this year, Johnson & Johnson & Johnson completed enrollment in the Omny-IRE clinical trial. That trial evaluates Omnypulse in Europe and Canada.
“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, VP, Scientific Affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “The ability to make personalized 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.”
