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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010188" target="_blank" >RIV/00023884:_____/25:00010188 - isvavai.cz</a>

Alternative codes found

RIV/00023001:_____/25:00085923

Result on the web

<a href="http://linkinghub-elsevier-com.ezproxy.lib.cas.cz/retrieve/pii/S2405500X25002580" target="_blank" >http://linkinghub-elsevier-com.ezproxy.lib.cas.cz/retrieve/pii/S2405500X25002580</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jacep.2025.04.008" target="_blank" >10.1016/j.jacep.2025.04.008</a>

Result language

angličtina

Original language name

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

Original language description

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) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

JACC: Clinical Electrophysiology

ISSN

2405-500X

e-ISSN

—

Volume of the periodical

11

Issue of the periodical within the volume

8

Country of publishing house

US - UNITED STATES

Number of pages

14

Pages from-to

1769-1782

UT code for WoS article

001595498700011

EID of the result in the Scopus database

2-s2.0-105004915436