Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2026
The Impact of a Visualized Steerable Sheath on Radiofrequency Catheter Ablation for First-Time Atrial Fibrillation Ablation: A Prospective, Randomized, Single-Blind Study.
Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundA 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.
aimsTo compare the impact of 3D-EAM visualized and nonvisualized steerable sheaths on procedural and clinical outcomes in patients undergoing AF ablation.
methodsThis 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.
resultsAcute 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).
conclusionsUsing 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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