Johnson & Johnson MedTech Completes Pilot Phase Enrollment of OMNY-AF Trial
Johnson & Johnson MedTech has 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 U.S. Food & Drug Administration (FDA) completes the review of the acute safety data from the pilot group.
The OMNYPULSE™ Platform, consisting of the OMNYPULSE™ Catheter 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.i 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.1 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,ii 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,iii 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 electroanatomical 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.2 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.3 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.4,5 Catheter ablation is a safe and effective rhythm-control strategy for symptomatic AFib patients who do not benefit from medication.6, iv
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. Learn more about both studies and our approach to PFA. The OMNYPULSE™ Platform is under development and not available for sale in any region of the world.
Footnotes
i. Compared to Wilson’s Central Terminal (WCT). Based on a benchtop study (n=3). TR-0028829 Rev A.
ii. Massachusetts General Hospital entered into a clinical trial agreement with Johnson & Johnson. for their participation in the OMNY-AF Study. Dr. Moussa Mansour served as a study coinvestigator. Dr. Mansour serves as a consultant for BWI. Dr. Mansour was not compensated for contribution to this announcement.
iii. St. David’s Medical Center entered into a clinical trial agreement with Johnson & Johnson. for their participation in the OMNY-AF Study. Dr. Andrea Natale served as a study coinvestigator. Dr. Natale serves as a consultant for BWI. Dr. Natale was not compensated for this for his contribution to this announcement.
iv. When compared to drug therapy. Results may vary.
v. Timepoints specified in the protocol.
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1 Biosense Webster. (2023). OMNYPULSE™ Bi-Directional Catheter IFU.
2 Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.
3 Staerk, L, Wang, B, Preis, SR et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. doi: 10.1136_bmj.k1453 | BMJ 2018;361:k1453
4 Dilaveris PE, Kennedy HL. Silent Atrial Fibrillation: Epidemiology, Diagnosis, and Clinical Impact. Clin Cardiol. 2017;40:413–418.
5 Benjamin EJ, Go AS, Desvigne-Nickens P, et al. Research Priorities in Atrial Fibrillation Screening: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop. Circulation. 2021;143:372–388.
6 Loring Z, Matsouaka RA, Holmes DN. Procedural Patterns and Safety of Atrial Fibrillation Ablation.
Source: Johnson & Johnson MedTech