Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial

• Published in: Nature medicine Vol. 30; no. 8; pp. 2303 - 2310
• Main Authors: Anter, Elad, Mansour, Moussa, Nair, Devi G., Sharma, Dinesh, Taigen, Tyler L., Neuzil, Petr, Kiehl, Erich L., Kautzner, Josef, Osorio, Jose, Mountantonakis, Stavros, Natale, Andrea, Hummel, John D., Amin, Anish K., Siddiqui, Usman R., Harlev, Doron, Hultz, Paul, Liu, Shufeng, Onal, Birce, Tarakji, Khaldoun G., Reddy, Vivek Y.
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01-08-2024; Nature Publishing Group
• Subjects: 692/308/2779/777; 692/699/75/29/1309; 692/700/565/2773; Ablation; Aged; Arrhythmia; Atrial Fibrillation - surgery; Atrial Fibrillation - therapy; Biomedical and Life Sciences; Biomedicine; Blanking; Cancer Research; Cardiac arrhythmia; Catheter Ablation - methods; Catheters; Effectiveness; Female; Fibrillation; Humans; Infectious Diseases; Lesions; Male; Medical instruments; Metabolic Diseases; Middle Aged; Molecular Medicine; Neurosciences; Patients; Population studies; Radio frequency; Radiofrequency ablation; Recurrence; Secondary analysis; Single-Blind Method; Treatment Outcome
• ISSN: 1078-8956; 1546-170X; 1546-170X
• DOI: 10.1038/s41591-024-03022-6

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
.
In a randomized trial testing two types of catheter ablation treatments for persistent atrial fibrillation, a large-tip, dual pulsed field and radiofrequency catheter with a large footprint was non-inferior to a conventional radiofrequency catheter.