Rationale and study design for empirical additional lesions for premature ventricular complex from the outflow tract: a multi-center, prospective randomized trial (EASE-PVC study)

Abstract

Background Late recurrence after ablation remains a significant issue in patients with premature ventricular complexes (PVCs) who undergo catheter ablation. In this study, we aimed to test the hypothesis that empirical additional ablation (EAA) would improve the long-term control of PVCs from outflow tracts (OT-PVCs) compared with the approach of limited single point ablation at the assumptive location. Methods EASE-PVC study (ChiCTR2200055340) is a prospective multi-center, randomized, and controlled trial designed to assess the effectiveness and safety of empirical additional ablation in patients with OT-PVCs. After successful elimination of OT-PVCs, the patients will be randomized into two groups. In patients randomized to the EAA group, additional lesion applications at sites surrounding the successful ablation site will be delivered empirically. For patients randomized to the control group, no additional empiric ablation will be performed around the successful ablation site. The primary endpoint will be freedom from PVC recurrence at 3 months following ablation, without antiarrhythmic drug therapy. Conclusions The EASE-PVC study is designed to compare the effectiveness and safety of two different strategies for ablation in patients with OT-PVCs, namely empirical additional ablation strategy versus conventional single point ablation strategy. This prospective, multi-center, and randomized controlled trial, with comparative data evaluating procedural and long-term follow-up results, aims to elucidate the superiority of empirical additional ablation for the long-term control of OT-PVCs compared with the traditional single point ablation strategy. Clinical trial registration Chinese Clinical Trials Registry Identifier: ChiCTR2200055340.

Radiofrequency ablation of premature ventricular contractions guided by robotic magnetic navigation combined with pattern matching filter

“…The temperature control setting was set with an upper limit of 43°C, and the flow setting of normal saline during ablation was 17–20 mL/min. If PVCs reduction or elimination was observed within 10 s after ablation energy delivery, we continued to ablate for 90–120 s, otherwise terminated ablation, and mapped to find the new ablation site 12 . After the first ablation, isoproterenol was injected intravenously, and the patient observed for 30 min.…”

“…If PVCs reduction or elimination was observed within 10 s after ablation energy delivery, we continued to ablate for 90–120 s, otherwise terminated ablation, and mapped to find the new ablation site. 12 After the first ablation, isoproterenol was injected intravenously, and the patient observed for 30 min. If there was no PVCs recurrence, the procedure was defined as an acute success.…”