JACC. Clinical electrophysiology · 2026
Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation: 1-Year Outcomes of the VOLT-AF IDE Study.
Clinical StudyСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Verma Atul, Lo Monica, Woods Christopher E, Hussein Ayman A, Gambhir Alok, Sundaram Sri, Sanders Prashanthan, DeLurgio David, Mountantonakis Stavros E, Neuzil Petr, Osca Joaquin, Trivedi Amar, Loh Peter, Calkins Hugh, Strouse David, Chierchia Gian-Battista, Atwater Brett, Kalman Jonathan, Puererfellner Helmut, Russo Antonio Dello, Davoudi Ramin, Schilling Richard, Lin Wenjiao, Miller Amber, Jesser Emily, Lakkireddy Dhanunjaya
Аннотация
BACKGROUND: A novel balloon-in-basket catheter integrated into a mapping system may advance pulsed field ablation (PFA) of atrial fibrillation (AF) with demonstrated deeper lesions, less hemolysis, and promising initial clinical experience.
OBJECTIVES: The goal of this study was to assess the 1-year clinical outcomes of the balloon-in-basket PFA system.
METHODS: The multicenter VOLT-AF IDE Clinical Study enrolled patients with symptomatic, paroxysmal (PAF), and persistent AF (PeAF) . Pulmonary vein isolation (PVI) was performed with the investigational system. The primary effectiveness endpoint was acute PVI and 12-month freedom from atrial arrhythmia, antiarrhythmic escalation/initiation, cardioversion, or repeat ablation. The primary safety endpoint was device- and/or procedure-related serious adverse events within 7 days of any ablation. Follow-up consisted of 12-lead electrocardiograms at discharge, 3 months, and 12 months; biweekly and symptomatic transtelephonic monitoring; and 24-hour Holter monitoring at 12 months.
RESULTS: Of the 392 patients enrolled, 335 were main cohort patients (57 roll-ins), and 320 were treated (165 PAF and 155 PeAF). Their mean age was 65 ± 11 years, and the mean CHA2DS2-VASc score was 2.3 ± 1.6. Left atrial catheter dwell time was 44.1 ± 18.1 minutes (including a 20-minute wait). A mean of 4.6 ± 0.9 applications were delivered per vein. Primary effectiveness was 81.1% (95% CI: 74.3%-86.3%) in PAF and 63.3% (95% CI: 55.1%-70.4%) in PeAF. Freedom from documented arrhythmia recurrence was 84.2% in the PAF group and 67.8% in the PeAF group. Primary safety events occurred in 1.9% of patients, with none in the PAF group. During redo ablation in 19 patients, 78.5% of pulmonary veins remained durably isolated.
CONCLUSIONS: This multicenter trial reports high PVI-based effectiveness of the novel balloon-in-basket PFA device with excellent safety.(VOLT-AF IDE Clinical Study; NCT06223789).
OBJECTIVES: The goal of this study was to assess the 1-year clinical outcomes of the balloon-in-basket PFA system.
METHODS: The multicenter VOLT-AF IDE Clinical Study enrolled patients with symptomatic, paroxysmal (PAF), and persistent AF (PeAF) . Pulmonary vein isolation (PVI) was performed with the investigational system. The primary effectiveness endpoint was acute PVI and 12-month freedom from atrial arrhythmia, antiarrhythmic escalation/initiation, cardioversion, or repeat ablation. The primary safety endpoint was device- and/or procedure-related serious adverse events within 7 days of any ablation. Follow-up consisted of 12-lead electrocardiograms at discharge, 3 months, and 12 months; biweekly and symptomatic transtelephonic monitoring; and 24-hour Holter monitoring at 12 months.
RESULTS: Of the 392 patients enrolled, 335 were main cohort patients (57 roll-ins), and 320 were treated (165 PAF and 155 PeAF). Their mean age was 65 ± 11 years, and the mean CHA2DS2-VASc score was 2.3 ± 1.6. Left atrial catheter dwell time was 44.1 ± 18.1 minutes (including a 20-minute wait). A mean of 4.6 ± 0.9 applications were delivered per vein. Primary effectiveness was 81.1% (95% CI: 74.3%-86.3%) in PAF and 63.3% (95% CI: 55.1%-70.4%) in PeAF. Freedom from documented arrhythmia recurrence was 84.2% in the PAF group and 67.8% in the PeAF group. Primary safety events occurred in 1.9% of patients, with none in the PAF group. During redo ablation in 19 patients, 78.5% of pulmonary veins remained durably isolated.
CONCLUSIONS: This multicenter trial reports high PVI-based effectiveness of the novel balloon-in-basket PFA device with excellent safety.(VOLT-AF IDE Clinical Study; NCT06223789).