Zhe Wang1, Fangyi Xiao2, Fu Yi3, Chengzong Li4, Long Chen5, Cao Zou6, Yuzhen Zhang6, Yuegang Wang7, Yuan Ji8, Zhongbao Ruan9, Wenzhi Shen10, Linsheng Shi11, Yumin Sun12, Youquan Wei13, Qiang Xu14, Chen Wang1, Weizhu Ju15, Minglong Chen1. 1. Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Guangzhou Road 300, Nanjing, 210029, China. 2. Department of Cardiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. 3. Department of Cardiology, Xijing Hospital, Air Force Medical University, Xi'an, China. 4. Department of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. 5. Department of Cardiology, School of Medicine, Zhongda Hospital, Southeast University, Nanjing, China. 6. Department of Cardiology, The First Affiliated Hospital of Soochow University, Soochow, China. 7. Department of Cardiology, Nanfang Hospital, Southern Medical University, Guangzhou, China. 8. Department of Cardiology, Changzhou No.2 People's Hospital, The Affiliated Hospital of Nanjing Medical University, Changzhou, China. 9. Department of Cardiology, Taizhou People's Hospital, Taizhou, China. 10. Department of Cardiology, Nanjing Drum Tower Hospital, Nanjing, China. 11. Department of Cardiology, The Second Affiliated Hospital of Nantong University, Nantong, China. 12. Department of Cardiology, Jing'an District Centre Hospital of Shanghai, Fudan University, Shanghai, China. 13. Department of Cardiology, The First Affiliated Yijishan Hospital of Wannan Medical College, Wuhu, China. 14. Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, China. 15. Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Guangzhou Road 300, Nanjing, 210029, China. juweizhu@126.com.
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.
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.
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