17 May 2024 | A list of authors and their affiliations appears at the end of the paper
The SPHERE Per-AF trial evaluated the safety and effectiveness of a dual-energy lattice-tip ablation system for persistent atrial fibrillation (AF) compared to conventional radiofrequency ablation. The study was a randomized, single-blind, non-inferiority trial involving 420 patients. The primary composite effectiveness endpoint, which included freedom from acute procedural failure, repeat ablation, arrhythmia recurrence, and drug initiation or escalation, was observed in 73.8% of patients in the investigational group and 65.8% in the control group (P < 0.0001 for non-inferiority). The primary safety endpoint, which included serious procedure-related or device-related adverse events, occurred in 1.4% of patients in the investigational group and 1.0% in the control group (P < 0.0001 for non-inferiority). Procedural times were shorter in the investigational group (P < 0.0001). The dual-energy lattice-tip ablation system demonstrated non-inferior safety and effectiveness compared to conventional radiofrequency ablation, with improved procedural efficiency. Future studies are needed to further evaluate the broader population of patients with AF.The SPHERE Per-AF trial evaluated the safety and effectiveness of a dual-energy lattice-tip ablation system for persistent atrial fibrillation (AF) compared to conventional radiofrequency ablation. The study was a randomized, single-blind, non-inferiority trial involving 420 patients. The primary composite effectiveness endpoint, which included freedom from acute procedural failure, repeat ablation, arrhythmia recurrence, and drug initiation or escalation, was observed in 73.8% of patients in the investigational group and 65.8% in the control group (P < 0.0001 for non-inferiority). The primary safety endpoint, which included serious procedure-related or device-related adverse events, occurred in 1.4% of patients in the investigational group and 1.0% in the control group (P < 0.0001 for non-inferiority). Procedural times were shorter in the investigational group (P < 0.0001). The dual-energy lattice-tip ablation system demonstrated non-inferior safety and effectiveness compared to conventional radiofrequency ablation, with improved procedural efficiency. Future studies are needed to further evaluate the broader population of patients with AF.