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).

AZORG Cardiovascular Center Aalst Belgium

Cardioangiologisches Centrum Bethanien Medizinische Klinik 3 Agaplesion Markus Krankenhaus Frankfurt am Main Germany

Cardiology Department Jessa Hospitals Hasselt Belgium

Centre for Cardiology and Angiology Department of Cardiovascular Diseases Vilnius University Vilnius Lithuania

Department of Cardiology AZ Sint Jan Hospital Bruges Belgium

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czech Republic

Department of Cardiology Maastricht University Medical Centre and Cardiovascular Research Institute Maastricht Maastricht the Netherlands

Department of Cardiology Na Homolce Hospital Prague Czech Republic

Heart Rhythm Management Centre Postgraduate Program in Cardiac Electrophysiology and Pacing Universitair Ziekenhuis Brussel Vrije Universiteit Brussel European Reference Networks Guard Heart Brussels Belgium

Helmsley Electrophysiology Center Mount Sinai Fuster Heart Hospital New York New York USA

Hirslanden St Anna Lucerne Switzerland

McGill University Health Centre McGill University Montreal Quebec Canada

Montreal Heart Institute Department of Medicine Université de Montréal Montreal Quebec Canada

Ospedale Generale Regionale F Miulli UOC Cardiologia Acquaviva delle Fonti Bari Italy

University Hospital Center Split Split Croatia

Ziekenhuis Oost Limburg Genk Belgium

Citace poskytuje Crossref.org

Zobrazit více v PubMed

ClinicalTrials.gov
NCT05971693