Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .

Cleveland Clinic Cleveland OH USA

Department of Biomedicine and Prevention Division of Cardiology University of Tor Vergata Rome Italy

Division of Cardiology Ohio State University Columbus OH USA

Florida Cardiology Orlando FL USA

HCA Florida Miami Miami FL USA

Helmsley Electrophysiology Center Mount Sinai Fuster Heart Hospital New York NY USA

IKEM Prague Prague Czechia

Massachusetts General Hospital Boston MA USA

Medtronic Mounds View MN USA

Na Homolce Hospital Prague Czechia

NCH Rooney Heart Institute Naples FL USA

Northwell New Hyde Park NY USA

Riverside Methodist Hospital Upper Arlington OH USA

Sentara Norfolk VA USA

Shamir Medical Center Be'er Ya'Akov Israel

St Bernards Medical Center and Arrhythmia Research Group Jonesboro AR USA

Texas Cardiac Arrhythmia Institute Austin TX USA

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Mapping and ablation of ventricular tachycardia using dual-energy lattice-tip focal catheter: early feasibility and safety study

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ClinicalTrials.gov
NCT05120193