Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent AF: Volt-AF IDE trial acute results

Abstract

Background: Increasing use of Pulsed Field Ablation (PFA) to treat atrial fibrillation (AF) has led to concerns related to tissue contact, hemolysis, and electroanatomic mapping integration. A novel balloon-in-basket PFA catheter offers form and function to address these concerns. Objective: The VOLT-AF Investigational Device Exemption (IDE) study is a prospective, single-arm global IDE study designed to demonstrate the Volt PFA system (Abbott Laboratories, Chicago, Illinois) is safe and effective for the treatment of paroxysmal AF (PAF) and persistent AF (PersAF). Methods: Symptomatic, drug-refractory PAF and PersAF subjects were enrolled for de novo ablation. Ablation strategy was pulmonary vein isolation-only using the Volt PFA catheter with EnSite X EP System integration for visualization and dynamic contact display. End points were the rate of the device- or procedure-related SAE within 7 days and acute procedural success. Results: A total of 392 subjects (57 roll-in, 335 primary analysis, 51.8% PAF, 64.7% men, age 65.0 ± 11.0 years) were enrolled at 38 sites from April to September 2024. Acute isolation was observed in 99.4% of veins (666/670) in 98.2% of patients with PAF (162/165), and in 99.8% of veins (633/634) in 99.4% of patients with PersAF (154/155), with 18.5 ± 3.6 applications/patient. Primary safety endpoint events occurred in 1.9% of subjects. Procedural efficiency and acute outcomes did not differ with fluoroscopy use. Conscious or deep sedation was associated with increased procedural efficiency, with no difference in acute success compared with general anesthesia. No clinically relevant hemolysis or kidney injury was reported. Conclusion: These results demonstrate the acute safety and effectiveness of a novel balloon-in-basket PFA catheter to treat paroxysmal and persistent AF. Long-term outcome follow-up is ongoing.