Study design
This study was designed as a single-center, prospective, single-blind, randomized, controlled clinical trial to evaluate the periprocedural incidence of SCE in AF patients undergoing catheter ablation with the HPSD strategy versus the conventional approach. From June 2020 to September 2021, 100 AF patients undergoing their first catheter ablation procedure were enrolled in the study. Enrolled patients were randomly assigned to undergo catheter ablation with the HPSD strategy (HPSD group) or the conventional approach (Conventional group) using a randomization envelope. Patients in the HPSD group underwent point-by-point circumferential pulmonary vein ablation with the HPSD strategy (RF energy was set up at a power of 50 W, temperature of 43 °C, contact force of 5–20 g, and flow rate of 20 mL/min) using the novel STSF catheter. Patients in the conventional group underwent point-by-point circumferential pulmonary vein ablation with conventional settings (RF energy was set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5–20 g, and flow rate of 17 to 30 mL/min) using the ST catheter. The periprocedural incidence of SCE was determined by brain hDWI, which was performed 3 days before the procedure and re-evaluated 24–72 h after ablation. The study was approved by the ethics committee of the Second Affiliated Hospital of Chongqing Medical University and adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all enrolled patients.