Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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: -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).
Source: JACC. Clinical electrophysiology
Authors: Atul Verma, Monica Lo, Christopher E. Woods, Ayman A. Hussein, Alok Gambhir, Sri Sundaram, Prashanthan Sanders, David DeLurgio, Stavros E. Mountantonakis, Petr Neuzil, Joaquin Osca, Amar Trivedi, Peter Loh, Hugh Calkins, David Strouse, Gian-Battista Chierchia, Brett Atwater, Jonathan Kalman, Helmut Puererfellner, Antonio Dello Russo, Ramin Davoudi, Richard Schilling, Wenjiao Lin, Amber Miller, Emily Jesser, Dhanunjaya Lakkireddy
Institutions: McGill University Health Centre, Arkansas Heart Hospital, California Pacific Medical Center, Cleveland Clinic, Northside Hospital, Royal Adelaide Hospital, The University of Adelaide, Emory University Hospital, Lenox Hill Hospital, Na Homolce Hospital, Hospital Universitari i Politècnic La Fe, University Medical Center Utrecht, Johns Hopkins University, Johns Hopkins Hospital, MedStar Washington Hospital Center, Washington Hospital, Inova Health System, The Royal Melbourne Hospital, Krankenhaus der Elisabethinen, Azienda Ospedaliero-Universitaria delle Marche, Charlton Memorial Hospital, St Bartholomew's Hospital, Kansas City Heart Rhythm Institute
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,000
Funder: Abbott Vascular
OpenAlex ID: W7127893336