| Title |
PVI with CF-sensing large-tip focal PFA catheter with 3D mapping for paroxysmal AF: Omny-IRE 3-month results |
| Authors |
Duytschaever, Mattias ; Grimaldi, Massimo ; De Potter, Tom ; Verma, Atul ; Macle, Laurent ; Kautzner, Josef ; Linz, Dominik ; Anic, Ante ; Van Herendael, Hugo ; Račkauskas, Gediminas ; Neuzil, Petr ; Chun, Julian ; Schmidt, Boris ; Knecht, Sebastien ; Almorad, Alexandre ; Berte, Benjamin ; Reddy, Vivek Y ; Vijgen, Johan |
| DOI |
10.1016/j.jacep.2025.04.008 |
| Full Text |
|
| Is Part of |
JACC: Clinical electrophysiology.. Amsterdam : Elsevier Inc.. 2025, Early Access, p. [1-14].. ISSN 2405-500X. eISSN 2405-5018 |
| Keywords [eng] |
contact force catheter ; large-tip focal ; PF index ; pulmonary vein isolation ; pulsed field ablation |
| Abstract [eng] |
Background: Omny-IRE (A Study For Treatment of Paroxysmal Atrial Fibrillation [PAF] With the OMNYPULSE Catheter and the TRUPULSE Generator; NCT05971693) evaluated safety and effectiveness of a novel large-tip focal, multielectrode, contact force–sensing, pulsed field ablation catheter with electroanatomic mapping integration. Objectives: This study sought to assess 3-month safety and effectiveness of the platform for treating symptomatic paroxysmal atrial fibrillation. Methods: Pulmonary vein isolation (PVI) was performed using the OMNYPULSE Platform. Primary effectiveness was adenosine/isoproterenol-proof entrance block. Primary safety was occurrence of primary adverse events. Prespecified patient subsets underwent systematic brain imaging, esophageal endoscopy, cardiac computed tomography/magnetic resonance angiogram, and mandatory 3-month remapping for PVI durability assessment. Results: Of 188 patients enrolled, 136 were included in the per-protocol analysis. Primary effectiveness was 100% (136 of 136). Median (Q1-Q3) procedure, left atrial dwell, total ablation, and total fluoroscopy times were 105.5 (91.0-124.0), 70.0 (56.0-81.5), 46.9 (37.1-58.8), and 5.0 (3.1-9.8) minutes, respectively. The primary adverse event rate was 3.0% (4 of 135 patients with 3-month follow-up; 3 major vascular access complications, 1 pericarditis). Brain imaging (n = 30) revealed 1 patient (3.3%) with an asymptomatic silent cerebral event at discharge, which resolved at 1 month without neurological change. No esophageal injury was observed. Computed tomography/magnetic resonance angiogram imaging (n = 24) showed no incidences of pulmonary vein narrowing >70%. During remapping, PVI was durable in 84.5% (98 of 116) of veins and 62.1% (18 of 29) of patients. With an optimized workflow, PVI durability improved to 89.3% (75 of 84) and 71.4% (15 of 21) of veins and patients, respectively. Conclusions: The force-sensing, large-focal pulsed field ablation catheter with 3-dimensional electroanatomic mapping integration showed 100% acute success with a promising safety profile for treating paroxysmal atrial fibrillation. Prespecified remapping showed good PVI durability. (A Study For Treatment of Paroxysmal Atrial Fibrillation [PAF] With the OMNYPULSE Catheter and the TRUPULSE Generator; NCT05971693). |
| Published |
Amsterdam : Elsevier Inc |
| Type |
Journal article |
| Language |
English |
| Publication date |
2025 |
| CC license |
|
