Enrollment is complete in the pilot phase of the OMNY-AF clinical trial,which evaluates the OMNYPULSE Platform in the treatment of symptomatic paroxysmal atrial fibrillation (AFib).J&J

 Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the enrollment completion of the pilot phase of the OMNY-AF clinical trial, a study which evaluates the investigational OMNYPULSE Platform in the treatment of symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia.

OMNY-AF is a prospective, single-arm, multi-center clinical trial that has completed the pilot phase enrollment of 30 patients and will enroll up to 410 additional patients in the pivotal phase across the United States and Australia. The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of the OMNYPULSE Platform for pulmonary vein isolation in the treatment of subjects with symptomatic paroxysmal AFib. The pivotal phase of the study will begin once the FDA  completes the review of the acute safety data from the pilot group.

The OMNYPULSE Platform, consisting of the OMNYPULSE Catheter  (see separate entry) and TRUPULSE  Generator, is designed to enable AFib treatment strategies with a catheter that combines Pulsed Field Ablation (PFA) therapy and mapping via the CARTO  3 System, the world’s leading 3D heart mapping system. The investigational OMNYPULSE Catheter is a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref  reference electrode to reduce the impact of far-field unipolar signals.  The investigational TRUPULSE Generator provides a bipolar, biphasic pulse application to the catheter’s twelve electrodes. With the CARTO  3 System, clinicians are able to obtain a Pulsed Field Index value, which is a calculation using the real-time contact force feedback combined with the number of pulsed field applications.  This value can then be compared to the recommended Pulsed Field Index value, acting as an ablation target for a given location.

“The CARTO  3 System integrated with the OMNYPULSE Platform and the PF Index module allows me to correlate my ablation parameters with each lesion I create in real-time”, said Dr. Moussa Mansour ⁱ director of the atrial fibrillation program at Massachusetts General Hospital. “This tool could potentially increase procedure efficiency and treatment accuracy.”

“When treating AFib, mapping system integration is just as important with pulsed field energy as it was with other energy sources”, said Dr. Andrea Natale, Executive Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, who conducted one of the first patient cases. “The OMNYPULSE Platform is designed to provide PFA energy with contact force guidance and electro-anatomical mapping with CARTO.”

“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, Ph.D., Vice President, 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.”

AFib is the most common type of cardiac arrhythmia and affects more than 8 million people in the U.S. and nearly 50 million people worldwide. Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.  Despite these projections, about one-third of patients with AFib are not aware they have the condition, and AFib often goes unrecognized until the onset of complications. Catheter ablation is a safe and effective rhythm-control strategy for symptomatic AFib patients who do not benefit from medication.

Earlier this year, Johnson & Johnson MedTech completed enrollment of the Omny-IRE clinical trial, which is evaluating the safety and efficacy of the OMNYPULSE Platform in Europe and Canada. 

About The OMNYPULSE   Platform; The investigational OMNYPULSE Platform uses pulsed electrical field energy to produce targeted intracardiac lesions for the treatment of AFib. The platform includes the TRUPULSE Generator and multi-electrode OMNYPULSE catheter used in conjunction with the CARTO 3 System with the VISITAG SURPOINT Module PF Index to provide electro- anatomical maps, contact force sensing, PF Index values and catheter localization information for ablations for the treatment of paroxysmal AFib.

About The OMNY-AF Study; The OMNY-AF study is a prospective, single-arm, multi-center study evaluating the clinical safety and effectiveness of the OMNYPULSE. Catheter for the treatment of symptomatic paroxysmal AFib. Up to 440 enrolled subjects will undergo an ablation procedure with the OMNYPULSE Platform. The primary safety endpoint in the study is the occurrence of Primary Adverse Events within seven days of the ablation procedure.  The primary effectiveness endpoint is freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia episodes based on electrocardiographic data and additional failure modes during the effectiveness evaluation period over a 12-month period.