Johnson & Johnson Medical Technologies has announced the successful completion of the recruitment for the pilot phase of clinical trials for its Omnypulse platform.

This clinical trial, named OMNY-AF, aims to evaluate the effectiveness of the platform in treating symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia.This single-arm, multi-center trial has successfully completed the initial recruitment of 30 patients, and Johnson & Johnson expects to further recruit up to 410 patients in the upcoming critical phase.

Headquartered in Irvine, California, Johnson & Johnson's primary goal for the trial is to verify the safety and 12-month efficacy of the Omnypulse platform in performing pulmonary vein isolation (PVI) treatment for patients with symptomatic paroxysmal atrial fibrillation. The pivotal phase of the trial is expected to commence after the FDA completes its review of the acute safety data from the pilot group.

The Omnypulse platform combines the Omnypulse catheter and the Trupulse generator. The catheter is a large-tip, 12-millimeter device integrated with the Carto 3 system, featuring contact force feedback and enhanced mapping capabilities, achieving the perfect combination of pulsed field ablation (PFA) therapy and mapping.

At the same time, the Trupulse generator under development can provide bipolar biphasic pulse sequences to the 12 electrodes of the catheter during cardiac ablation. Equipped with contact force sensing and the Trueref reference electrode, it effectively reduces the impact of far-field unipolar signals. Johnson & Johnson designed this platform with the aim of achieving a comprehensive AFib treatment strategy through a single device, which is capable of both large-area ablation and creating high-density maps.

It is worth mentioning that,Earlier this year, Johnson & Johnson completed the recruitment for the Omny-IRE clinical trial, which evaluated the Omnypulse platform in Europe and Canada.。

Jennifer Currin, Vice President of Scientific Affairs for Cardiovascular and Specialty Solutions at Johnson & Johnson MedTech, stated: "The OMNY-AF study is part of our ongoing effort to provide electrophysiologists with efficient and effective ablation tools to achieve positive treatment outcomes for AFib patients. By offering a solution that integrates assessment and treatment, electrophysiologists can make more personalized treatment decisions, which will bring significant value to both physicians and patients."

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