Key result
3D-EAM visualized steerable sheath cuts fluoroscopy time by ~26% vs conventional sheath during RF ablation.
Why the study?
Prospective randomized data comparing the procedural and clinical outcomes of 3D-EAM visualized versus non-visualized steerable sheaths during AF ablation were limited.
Does a 3D-EAM-visualized steerable sheath reduce fluoroscopy time and dose in patients undergoing first-time atrial fibrillation ablation?
RCT (n=100)
Single-blind
1:1 ratio using REDCap
No
Does a 3D-EAM-visualized steerable sheath reduce fluoroscopy time and dose in patients undergoing first-time atrial fibrillation ablation?
Using a visualized steerable sheath during AF ablation significantly reduces radiation exposure and improves left-sided first-pass pulmonary vein isolation without prolonging procedure time.
Supports adoption of visualized steerable sheaths to minimize radiation in AF ablation; extends randomized evidence for procedural optimization.
BACKGROUND: A 3D electroanatomical mapping (3D-EAM) visualized steerable sheath was designed to improve catheter placement and reduce radiation exposure during ablation, an established treatment for atrial fibrillation (AF). However, prospective randomized data comparing the procedural and clinical outcomes of visualized and non-visualized steerable sheaths are limited. AIMS: To compare the impact of 3D-EAM visualized and nonvisualized steerable sheaths on procedural and clinical outcomes in patients undergoing AF ablation. METHODS: This prospective randomized study included 100 patients who underwent radiofrequency catheter ablation for AF. Patients were randomized (1:1) to either a 3D-EAM-visualized steerable sheath (Vizigo) or a conventional non-visualized steerable sheath (Agilis) group. Key endpoints included procedure and fluoroscopy times, pulmonary vein isolation (PVI) effectiveness, and 12-month AF recurrence. RESULTS: Acute PVI was successfully achieved in all patients. Fluoroscopy time was significantly lower in the Vizigo group than that in the Agilis group (11.43 vs. 15.37 min, p = 0.0013), with a zero-fluoroscopy workflow achievable post-transseptal puncture. First-pass PVI success in left-sided veins was significantly higher in the Vizigo group than that in the Agilis group (84% vs. 64%, p = 0.023). At the 12-month follow-up, AF-free survival was favored in the Vizigo group (91.8% vs. 83.3%; p = 0.203). CONCLUSIONS: Using a 3D-EAM visualized steerable sheath significantly reduced fluoroscopy time without prolonging the AF ablation procedure, making a zero-fluoroscopy ablation strategy feasible after transseptal puncture. Furthermore, the improved left-sided first-pass PVI success observed with the Vizigo sheath may have implications for procedural efficacy, although its effect on long-term outcomes warrants further investigation with larger cohorts.
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Chen et al. (2026) conducted an RCT in Atrial Fibrillation (n=100). 3D-EAM-visualized steerable sheath (Vizigo) vs. Conventional non-visualized steerable sheath (Agilis) was evaluated on Fluoroscopy time (p=0.0013). The use of a 3D-EAM visualized steerable sheath significantly reduced fluoroscopy time compared to a conventional sheath (11.43 vs. 15.37 min, p=0.0013).
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