PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF

Mattias Duytschaever; Massimo Grimaldi; Tom De Potter; Atul Verma; Laurent Macle; Josef Kautzner; Dominik Linz; Ante Anić; Hugo Van Herendael; Gediminas Račkauskas; Petr Neužil; K. R. Julian Chun; Boris Schmidt; Sébastien Knecht; Alexandre Almorad; Benjamin Berte; Vivek Y. Reddy; Johan Vijgen

doi:10.1016/j.jacep.2025.04.008

Graphical abstract published by JACC. Clinical electrophysiology — Graphical abstract · Published by JACC. Clinical electrophysiology · CC BY 4.0

Why the study?

The study sought to assess the 3-month safety and effectiveness of a novel large-tip focal, multielectrode, contact force-sensing pulsed field ablation catheter with electroanatomic mapping integration for symptomatic paroxysmal AF.

Does a force-sensing, large-focal pulsed field ablation catheter with 3D mapping achieve effective and safe pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation?

Structured PICO

Does a force-sensing, large-focal pulsed field ablation catheter with 3D mapping achieve effective and safe pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation?

P

Population

188 enrolled patients (136 in per-protocol analysis) with symptomatic paroxysmal atrial fibrillation.

I

Intervention

Pulmonary vein isolation (PVI) using a novel large-tip focal, multielectrode, contact force-sensing, pulsed field ablation catheter with electroanatomic mapping integration (OMNYPULSE Platform).

O

Outcome

Adenosine/isoproterenol-proof entrance block (primary effectiveness) and occurrence of primary adverse events (primary safety).surrogate

The novel force-sensing, large-focal pulsed field ablation catheter demonstrated 100% acute success for pulmonary vein isolation with a low complication rate in patients with paroxysmal atrial fibrillation.

Implication

Supports feasibility of this novel PFA catheter for PVI; leaves open randomized confirmation of durability and safety.

Abstract

BACKGROUND: Omny-IRE (A Study For Treatment of Paroxysmal Atrial Fibrillation [PAF] With the OMNYPULSE Catheter and the TRUPULSE Generator) 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).