Johnson & Johnson's OMNY-AF study reveals 90% success in treating paroxysmal AFib

Johnson & Johnson has released promising 12-month results from the OMNY-AF study, a major clinical trial for treating symptomatic paroxysmal atrial fibrillation (AFib). The findings were presented at the 31st Annual AF Symposium in Boston, showcasing high success rates and strong safety outcomes in a 30-patient pilot group. The study combines advanced technology with precise energy delivery, marking a potential step forward in AFib treatment research. The OMNY-AF study is a prospective, single-arm trial conducted across over 40 sites in the U.S. and Australia. It tests the OMNYPULSE Catheter alongside the TRUPULSE Generator, both integrated with the CARTO 3 System for accurate mapping and controlled energy application. Early data revealed 100% acute procedural success with no adverse events linked to the procedure. In the 30-patient cohort, 56.7% of cases required no fluoroscopy, and 90% of patients met the primary effectiveness goal at 12 months. Dr. Dinesh Sharma, the study's presenting author, highlighted the smooth integration of mapping, ultrasound, and contact force measurements within the trial. At the same symposium, Johnson & Johnson also shared updated findings on the VARIPULSE Platform. After workflow improvements and an adjusted irrigation rate, the neurovascular event rate dropped to 0.22% among 6,811 patients. Dr. Gregory Michaud, Chief Medical and Scientific Officer for Electrophysiology at Johnson & Johnson, stressed the need for thorough evidence and open data sharing in pulse field ablation research. By early 2026, the OMNY-AF study had expanded to include over 150 medical centres worldwide, with contributions from countries such as Canada, Germany, France, the UK, Japan, and Brazil. Despite these advancements, the OMNYPULSE Platform remains unapproved in any region. The OMNY-AF study's results suggest strong procedural safety and effectiveness in treating paroxysmal AFib. With expanded global participation and refined workflows, the data may support future regulatory reviews. However, the OMNYPULSE Platform still awaits official approval for clinical use.