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

ABSTRACT 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