Randomized Controlled Trial Comparing Training of Transseptal Puncture With or Without Intracardiac Echocardiography

BACKGROUND: Intracardiac echocardiography (ICE) has been widely used in the catheter ablation of atrial fibrillation (AF). However, the value of ICE in the training of transseptal puncture (TSP) is unclear. METHODS: ICE-Training Study was a single-center, parallel-group, unmasked, randomized controlled trial registered in ChineseClinicalTrials.gov. Participants were randomly assigned (1:1) to different groups (1) the ICE simulator training group (ICE-ST), in which TSP was trained and performed under the guidance of both ICE and x-ray; and (2) the conventional simulator training group (Con-ST), in which TSP was trained and performed only under the guidance of x-ray. The trainees need to undergo the training stage and the evaluation stage. RESULTS: From October 2022 to December 2022, 18 consecutive fellows (age 32.4 ± 4.4 years, 12 males) without experience of TSP were included. The training period (16.9 ± 6.6 vs. 29.6 ± 8.7 times, p = 0.003) and the fluoroscopy time (120.3 ± 25.3 vs. 189.3 ± 40.2 s, p < 0.001) of the ICE-ST group was significantly shorter than that of the Con-ST group. No significant difference was found in the comprehensive performance of TSP in the ICE-ST group (composite score 96.7 ± 5.7) and the Con-ST group (composite score 95.9 ± 6.3, p = 0.62), but the selection of TSP sites in the ICE-ST group was commonly better than that in the Con-ST group. CONCLUSIONS: ICE could improve the efficiency of TSP training and optimize the site of TSP to facilitate catheter manipulation in the ablation. TRIAL REGISTRATION: ChineseClinicalTrials.gov identifier: ChiCTR2200058377.