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PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF: Omny-IRE 3-Month Results

M. Duytschaever, M. Grimaldi, T. De Potter, A. Verma, L. Macle, J. Kautzner, D. Linz, A. Anic, H. Van Herendael, G. Rackauskas, P. Neuzil, J. Chun, B. Schmidt, S. Knecht, A. Almorad, B. Berte, VY. Reddy, J. Vijgen

. 2025 ; 11 (8) : 1769-1782. [pub] 20250425

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc25022222

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).

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$a Duytschaever, Mattias $u Department of Cardiology, AZ Sint-Jan Hospital, Bruges, Belgium. Electronic address: Mattias.duytschaever@azsintjan.be
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$a 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).
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$a Verma, Atul $u McGill University Health Centre, McGill University, Montreal, Quebec, Canada
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$a Macle, Laurent $u Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada
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$a Chun, Julian $u Cardioangiologisches Centrum Bethanien (CCB), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt am Main, Germany
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