AIMS: Pulsed field ablation (PFA) is a growing ablation modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assesses the 6-month safety and effectiveness of a novel balloon-in-basket, mapping-integrated PFA system, with a purpose-built form factor for PVI. METHODS AND RESULTS: The VOLT CE Mark Study is a prospective, multi-center, pre-market study. A total of 150 patients with drug-refractory paroxysmal (PAF) or persistent AF (PersAF) were enrolled between 8 November 2023 and 14 March 2024, of which 146 patients (age 64.1 ± 10.0 years, 63.0% male, 70.5% PAF) underwent PVI with the balloon-in-basket PFA catheter and system featuring integrated electroanatomic mapping with contact-sensing. Study endpoints were the rate of primary serious adverse events within 7 days as well as acute procedural effectiveness and 6-month freedom from recurrence. Acute effectiveness was achieved in 99.1% (573/578) of treated PVs (98.6% of patients, 144/146) with 17.6 ± 5.7 PFA applications/patient. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 100.4 ± 33.0, 17.3 ± 12.1, 39.4 ± 20.6, and 31.4 ± 16.8 min, respectively. There were 4 (2.7%; 4/146) primary serious adverse events. The rate of freedom from documented atrial arrhythmias was 88.2% in PAF patients and 76.7% in PersAF patients (freedom from symptomatic recurrence was documented in 90.2% of PAF patients and 74.4% of PersAF patients) through 6-months post-index procedure. CONCLUSION: The VOLT CE Mark Study primary results demonstrate the safety and effectiveness of the novel balloon-in-basket PFA system to perform PVI in PAF and PersAF.

Cardiology Department Nemocnice Na Homolce Roentgenova 37 150 00 Praha 5 Czechia

Centre for Heart Rhythm Disorders University of Adelaide and Royal Adelaide Hospital Port Rd Adelaide SA 5000 Australia

Department of Cardiology and Intensive Care Medicine Asklepios Hospital St Georg Hamburg Germany

Department of Cardiology AZ Sint Jan Ruddershove 10 8000 Brugge Belgium

Department of Cardiology The Prince Charles Hospital 627 Rode Rd Chermside QLD 4032 Australia

Department of Cardiology UMC Utrecht Heidelberglaan 100 Utrecht 3584 CX Netherlands

Department of Cardiology University of Melbourne Royal Melbourne Hospital City Campus 300 Grattan Street Parkville Victoria 3050 Australia

Department of Cardiology Victorian Heart Hospital Monash Health 246 Clayton Road Clayton Victoria 3168 Australia

Department of Internal Medicine 2 with Cardiology Angiology and Intensive Care Medicine Ordensklinikum Linz Elisabethinen Linz Austria

Department of Rhythmology University Heart Center University Hospital Schleswig Holstein Lübeck Germany

Division of Cardiac Arrhythmias and Electrophysiology Cardiology Department Hospital Universitari i Politecnic La Fe Avinguda de Fernando Abril Martorell 106 Quatre Carreres 46026 València Valencia Spain

Electrophysiology Abbott Minneapolis MN USA

German Center for Cardiovascular Research Partner Site Hamburg Kiel Lübeck Lübeck Germany

Heart Rhythm Management Center UZ Brussels Vrij Universiteit Brussel Brussels Belgium

Kansas City Heart Rhythm Institute and Research Foundation 5100 W 100th St Suite 200 Overland Park KS 66211 USA

Mount Sinai Fuster Heart Hospital One Gustave L Levy Medical Place New York New York 10029 USA

Europace. 2025 Mar 28;27(4):euaf065. doi: 10.1093/europace/euaf065. PubMed

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