Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation: 1-Year Outcomes of the VOLT-AF IDE Study

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.

The goal of this study was to assess the 1-year clinical outcomes of the balloon-in-basket PFA system.

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.

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.

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).