Scott Buzby , 2025-05-09 13:20:00
Key takeaways:
- AF ablation with a novel contact force-sensing pulsed field catheter was safe and acutely effective.
- Three-month data show promising durability of pulmonary vein isolation.
First-in-human pulmonary vein isolation with a novel contact force-sensing pulsed field ablation catheter was safe and demonstrated promising 3-month durability for patients with paroxysmal atrial fibrillation, a speaker reported.
The results of the Omny-IRE study of a novel contact force-sensing, large-tip focal pulsed field ablation catheter (Omnypulse, Biosense Webster) for paroxysmal AF were presented at Heart Rhythm 2025.
“The Omnypulse platform is an investigational system that combines pulsed field ablation therapy and mapping via the CARTO 3 system to treat symptomatic paroxysmal atrial fibrillation,” Mattias Duytschaever, MD, electrophysiologist at AZ Sint-Jan Brugge Hospital in Bruges, Belgium, told Healio. “The Omnypulse catheter is the first large-tip, 12 mm large-focal catheter with contact force-sensing and a Trueref reference electrode to reduce the impact of far-field unipolar signals. The Trupulse generator provides a bipolar, biphasic pulse application to the catheter’s 12 electrodes. With the Carto 3 system software used in the study, clinicians were able to obtain a pulsed field index value for each ablation, which is calculated using real-time contact force feedback combined with the number of pulsed field applications.”
For the present prospective, single-arm, multicenter trial, the contact force-sensing pulsed field catheter, which also features 3D mapping, was tested for the first time in a cohort of 136 patients with paroxysmal AF at 13 centers in Europe and Canada (mean age, 60 years; 69% men).
The primary effectiveness endpoint was defined as adenosine/isoproterenol-confirmed pulmonary vein isolation (PVI), with a performance goal of 90%. The primary adverse events endpoint was defined as all procedure-related adverse events within 7 days of the procedure; cardiac tamponade/perforation within 30 days; and death, atrioesophageal fistula and pulmonary vein stenosis within 90 days, all with a performance goal of 12%.
In the present cohort, the average CHA2DS2-VASc score was 1.6, mean left ventricular ejection fraction was 59% and mean left atrium diameter was 39.6 mm.
Acute procedural success was achieved in 100% of patients.
Overall, 108 patients underwent PVI with a later optimized workflow with a recommended target pulsed field index of 550 on the anterior wall and 400 to 450 on the posterior wall.
“Following pulsed field index guidance plays a key role in promoting procedural consistency by quantifying energy delivery, contact force and lesion parameters,” Duytschaever told Healio. “This enables consistent dosing, and helps predict lesion depth based on validated preclinical models to drive lesion durability. As a result, the pulsed field index serves as a real-time procedural guide for physicians, helping them deliver improved patient outcomes.”
PVI with the contact force-sensing pulsed field ablation catheter was durable, with 84.5% of veins remaining isolated at a mean follow-up of 82 days, in a subgroup of 29 participants who underwent invasive remapping.
The average procedure time was 106 minutes, with a mean of 61 pulsed field ablations per procedure.
Four patients experienced adverse events. There were three cases of procedure-related vascular access-site complications and/or bleeding, but they were adjudicated as unrelated to the ablation catheter. There was one occurrence of pericarditis, which was adjudicated as possibly procedure-related, but unrelated to the ablation catheter. No other adverse events were reported.
“While direct head-to-head comparisons are not yet available, Omnypulse demonstrates comparable or superior acute success with high pulmonary vein durability paired with promising early safety,” Duytschaever said. “The next steps include ongoing patient follow-up, 12-month data analysis and advancing regulatory approvals based on safety and efficacy.”
Duytschaever said during the presentation that 12-month data from this European and Canadian cohort will be presented in the future, and a U.S. study is currently ongoing.
For more information:
Mattias Duytschaever, MD, can be reached at AZ Sint-Jan Hospital, Ruddershove 10, 8000 Brugge, Belgium, and at mattias.duytschaever@azsintjan.be.
Sources/Disclosures
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Duytschaever M, et al. Late-breaking clinical trials and science: Clinical trials updates and registries (non-ACE). Presented at: Heart Rhythm 2025; April 24-27, 2025; San Diego.
Disclosures:
The Omny-IRE trial was funded by Biosense Webster. Duytschaever reports no relevant financial disclosures.
