At a Glance
- Johnson & Johnson shares 12-month OMNY-AF pilot results
- 100% acute procedural success with OMNYPULSE pulsed field ablation for paroxysmal AF
- 90% of patients achieved effectiveness endpoint at 12 months
- Zero fluoroscopy in 57% of procedures
- New VARIPULSE Platform safety data highlighted
Written By: Nikita Chaudhari, BPharm
Reviewed By: Pharmacally Ediotrial Team
Johnson & Johnson has shared 12-month pilot-phase results from the OMNY-AF study, evaluating its investigational OMNYPULSE Platform in patients with symptomatic paroxysmal atrial fibrillation. The findings were presented at the 31st Annual AF Symposium in Boston.
In the 30-patient pilot cohort, physicians achieved 100% acute procedural success with no procedure-related adverse events. Notably, 56.7% of procedures used zero fluoroscopy, and 90% of patients met the study’s primary effectiveness endpoint at 12 months: early signs of strong safety and durability.
OMNY-AF Study Design and OMNYPULSE Technology
OMNY-AF is a prospective, single-arm, multicenter trial across more than 40 U.S. and Australian hospitals. It tests the OMNYPULSE system, a catheter-based tool that delivers pulsed electrical energy to cardiac sites triggering abnormal rhythms. The platform pairs with the TRUPULSE generator and CARTO 3 mapping system for real-time visualization and energy adjustments.
The full trial aims to enroll up to 440 patients, tracking safety via primary adverse events within seven days post-ablation and effectiveness through 12-month freedom from atrial tachyarrhythmia.
Dinesh Sharma, M.D., Section Head of Cardiac Electrophysiology at Naples Heart Institute and lead presenter, highlighted the lack of procedure-related adverse events or MRI-detected cerebral lesions. “The integrated mapping and contact-force feedback enabled precise, efficient pulsed field energy delivery,” he said.
Safety Updates for the Approved VARIPULSE Platform
Johnson & Johnson also presented fresh safety data on its VARIPULSE Platform. Andrea Natale, M.D., shared results published simultaneously in JACC: Clinical Electrophysiology by Moussa Mansour, M.D. showing a 0.22% neurovascular event rate in 6,811 patients after workflow tweaks and optimized irrigation.
Symposium highlights further bolstered the profile: An early VARISURE physician survey of 850 procedures found low complications and no deaths; REAL AF registry data reported a 0.5% acute safety event rate with zero neurovascular issues; and preclinical studies confirmed higher irrigation flows cut electrode heating without sacrificing lesion depth.
Broader View on Pulsed Field Ablation
Gregory Michaud, M.D., Chief Medical and Scientific Officer for Electrophysiology at Johnson & Johnson MedTech, stressed consistent safety across the company’s electrophysiology tools. “Pulsed field ablation technologies warrant individual evaluation, with ongoing evidence and transparent reporting as the field advances,” he noted.
As OMNY-AF enrollment progresses, larger datasets will clarify if these pilot safety and effectiveness signals hold in diverse atrial fibrillation populations.
References
Johnson & Johnson Presents Early Outcomes from the OMNY-AF Pilot Study at 2026 AF Symposium, 06 February 2026, Johnson & Johnson Presents Early Outcomes from the OMNY-AF Pilot Study at 2026 AF Symposium