Clinical Trial: Incidence and Anatomical Mechanisms of Unintentional Non-Pulmonary Vein Lesion Formation During Wire-Guided Single-Shot Pulsed-Field Ablation (Japan)

Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063270) titled 'Incidence and Anatomical Mechanisms of Unintentional Non-Pulmonary Vein Lesion Formation During Wire-Guided Single-Shot Pulsed-Field Ablation' on Oct. 15.

Study Type: Observational

Primary Sponsor: Institute - Kokura Memorial Hospital

Condition: Condition - atrial fibrillation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to determine the incidence and clinical characteristics of unintentional lesion formation involving structures adjacent to the pulmonary veins, particularly the left atrial appendage and mitral isthmus, during pulmonary vein isolation using wire-guided single-shot pulsed-field ablation (PFA). In addition, we aim to investigate potential anatomical and procedural mechanisms underlying these lesions using preprocedural cardiac computed tomography measurements of the spatial relationships between the pulmonary veins and adjacent structures, together with ex vivo assessment of PFA catheter geometry using an anatomical heart model. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients who underwent catheter ablation for atrial fibrillation. 2. Patients who underwent pulmonary vein isolation using a wire-guided single-shot PFA system, either FARAPULSE or PulseSelect. 3. Patients in whom post-ablation three-dimensional electroanatomical mapping was performed to assess pulmonary vein isolation and lesion distribution within the left atrium. Key exclusion criteria - 1. Patients treated using PFA systems other than FARAPULSE or PulseSelect. 2. Patients without adequate post-ablation electroanatomical mapping for assessment of lesion distribution. 3. Patients with insufficient clinical or imaging data required for the study analyses. Target Size - 655

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 09 Month 10 Day Anticipated trial start date - 2026 Year 09 Month 10 Day Last follow-up date - 2026 Year 09 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072020

Disclaimer: Curated by HT Syndication.