Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)

doi:10.1097/CD9.0000000000000032

科研成果详情

题名	Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)
作者	Jiang, Ruhong 1; Liu, Xingpeng 2; Zhang, Jidong 3; Chen, Yu 4; Wang, Rui 5; Wu, Mengzuo 6; Long, Deyong 7; Li, Jia 8; Wang, Haixiong 9; Fan, Jie 10; Ju, Weizhu 11; Ge, Weili 12; Liu, Xu 13; Deng, Hai 14; Wang, Weijian15; Yang, Pingzhen 16; Li, Ding 17; Huang, Xiaobo 18; Liu, Xiongtao 19; Tao, Hailong 20; Zei, Paul C.21; Tung, Roderick 1,22; Wang, Xunzhang 23; Jiang, Chenyang 1
发表日期	2021-12-01
发表期刊	Cardiology Discovery; 影响因子和分区
语种	英语
原始文献类型	Article
关键词	Atrial fibrillation Catheter ablation Intracardiac echocardiography Radiofrequency ablation
摘要	The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/ zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff. Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group (n = 216) and traditional approach group (n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this “minimal/zero-fluoroscopy” and “leadless” mode.
出版者	Wolters Kluwer Health
ISSN	2096-952X
EISSN	2693-8499
卷号	1 期号:4 页码:228-232
DOI	10.1097/CD9.0000000000000032
收录类别	SCOPUS
URL	查看原文
SCOPUSEID	2-s2.0-85146382120
通讯作者地址	[Jiang, Chenyang]Department of Cardiology,Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University,Zhejiang,Hangzhou,310016,China
Scopus学科分类	Cardiology and Cardiovascular Medicine
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/185218
专题	附属第二医院附属第一医院
通讯作者	Jiang, Chenyang
作者单位	1.Department of Cardiology,Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University,Zhejiang,Hangzhou,310016,China; 2.Cardiac Center,Beijing Chaoyang Hospital Affiliated to Capital Medical University,Beijing,100043,China; 3.Department of Sixth Cardiovascular Medicine,The Second Hospital of Hebei Medical University,Hebei,Shijiazhuang,050004,China; 4.Department of Cardiology,Sichuan Provincial People’s Hospital,Sichuan,Chengdu,610072,China; 5.Department of Cardiology,First Hospital of Shanxi Medical University,Shanxi,Taiyuan,030001,China; 6.Department of Cardiology,The First Affiliated Hospital of Anhui Medical University,Anhui,Hefei,230022,China; 7.Department of Cardiology,Beijing Anzhen Hospital,Capital Medical University,Beijing,100029,China; 8.Department of Cardiology,The Second Affiliated Hospital,Yuying Children’s Hospital of Wenzhou Medical University,Zhejiang,Wenzhou,325027,China; 9.Department of Cardiology,Shanxi Cardiovascular Hospital,Shanxi,Taiyuan,030024,China; 10.Division of Cardiology,The First Peoples’ Hospital of Yunnan Province,Yunnan,Kunming,650034,China; 11.Division of Cardiology,The First Affiliated Hospital of Nanjing Medical University,Jiangsu,Nanjing,210029,China; 12.Department of Cardiology,Taizhou Hospital of Zhejiang Province,Zhejiang,Taizhou,317000,China; 13.Department of Cardiology,Shanghai Chest Hospital,Shanghai,200030,China; 14.Department of Cardiology,Guangdong Provincial People’s Hospital,Guangdong,Guangzhou,510180,China; 15.Department of Cardiology,The First Affiliated Hospital of Wenzhou Medical University,Zhejiang,Wenzhou,325035,China; 16.Department of Cardiology,Zhujiang Hospital,Southern Medical University,Guangdong,Guangzhou,510260,China; 17.Department of Cardiology,Peking University People’s Hospital,Beijing,100044,China; 18.Department of Cardiology,Nanfang Hospital,Southern Medical University,Guangdong,Guangzhou,510515,China; 19.Department of Cardiology,Tangdu Hospital of Air Force Military Medical University,Shaanxi,Xi’an,710038,China; 20.Department of Cardiology,The First Affiliated Hospital of Zhengzhou University,Henan,Zhengzhou,450052,China; 21.Department of Medicine,Brigham and Women’s Hospital,Boston,02115,United States; 22.Center for Arrhythmia Care,Heart and Vascular Center,The University of Chicago Medicine,Pritzker School of Medicine,Chicago,60637,United States; 23.Heart Institute,Cedars Sinai Medical Center,Los Angeles,90048,United States
推荐引用方式 GB/T 7714	Jiang, Ruhong,Liu, Xingpeng,Zhang, Jidong,et al. Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)[J]. Cardiology Discovery;,2021,1(4):228-232.
APA	Jiang, Ruhong., Liu, Xingpeng., Zhang, Jidong., Chen, Yu., Wang, Rui., ... & Jiang, Chenyang. (2021). Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial). Cardiology Discovery;, 1(4), 228-232.
MLA	Jiang, Ruhong,et al."Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)".Cardiology Discovery; 1.4(2021):228-232.