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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)

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收录情况: ◇ 卓越:高起点新刊 ◇ ESCI ◇ 中华系列

机构: [1]Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Cardiol, Hangzhou, Zhejiang, Peoples R China [2]Capital Med Univ, Beijing Anzhen Hosp, Beijing Chaoyang Hosp, Beijing, Peoples R China [3]Hebei Med Univ, Dept Cardiovasc Med 6, Hosp 2, Shijiazhuang 050004, Hebei, Peoples R China [4]Sichuan Prov Peoples Hosp, Dept Cardiol, Chengdu 610072, Sichuan, Peoples R China [5]Shanxi Med Univ, Dept Cardiol, Hosp 1, Taiyuan 030001, Shanxi, Peoples R China [6]Anhui Med Univ, Dept Cardiol, Affiliated Hosp 1, Hefei 230022, Anhui, Peoples R China [7]Capital Med Univ, Beijing Anzhen Hosp, Dept Cardiol, Beijing 100029, Peoples R China [8]Wenzhou Med Univ, Affiliated Hosp 2, Dept Cardiol, Wenzhou 325027, Zhejiang, Peoples R China [9]Wenzhou Med Univ, Yuying Childrens Hosp, Wenzhou 325027, Zhejiang, Peoples R China [10]Shanxi Cardiovasc Hosp, Dept Cardiol, Taiyuan 030024, Shanxi, Peoples R China [11]First Peoples Hosp Yunnan Prov, Div Cardiol, Kunming 650034, Yunnan, Peoples R China [12]Nanjing Med Univ, Div Cardiol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China [13]Taizhou Hosp Zhejiang Prov, Dept Cardiol, Taizhou 317000, Zhejiang, Peoples R China [14]Shanghai Chest Hosp, Dept Cardiol, Shanghai 200030, Peoples R China [15]Guangdong Prov Peoples Hosp, Dept Cardiol, Guangzhou 510180, Guangdong, Peoples R China [16]Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou 325035, Zhejiang, Peoples R China [17]Southern Med Univ, Zhujiang Hosp, Dept Cardiol, Guangzhou 510260, Guangdong, Peoples R China [18]Peking Univ Peoples Hosp, Dept Cardiol, Beijing 100044, Peoples R China [19]Southern Med Univ, Nanfang Hosp, Dept Cardiol, Guangzhou 510515, Guangdong, Peoples R China [20]Air Force Mil Med Univ, Dept Cardiol, Tangdu Hosp, Xian 710038, Shaanxi, Peoples R China [21]Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou 450052, Henan, Peoples R China [22]Brigham & Womens Hosp, Dept Med, Boston, MA 02115 USA [23]Univ Chicago Med, Ctr Arrhythmia Care, Heart & Vasc Ctr, Pritzker Sch Med, Chicago, IL 60637 USA [24]Cedars Sinai Med Ctr, Heart Inst, Los Angeles, CA 90048 USA
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关键词: Atrial fibrillation Catheter ablation Intracardiac echocardiography Radiofrequency ablation

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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.

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第一作者机构: [1]Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Cardiol, Hangzhou, Zhejiang, Peoples R China
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