TY - JOUR
T1 - Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation
T2 - A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)
AU - Jiang, Ruhong
AU - Liu, Xingpeng
AU - Zhang, Jidong
AU - Chen, Yu
AU - Wang, Rui
AU - Wu, Mengzuo
AU - Long, Deyong
AU - Li, Jia
AU - Wang, Haixiong
AU - Fan, Jie
AU - Ju, Weizhu
AU - Ge, Weili
AU - Liu, Xu
AU - Deng, Hai
AU - Wang, Weijian
AU - Yang, Pingzhen
AU - Li, Ding
AU - Huang, Xiaobo
AU - Liu, Xiongtao
AU - Tao, Hailong
AU - Zei, Paul C.
AU - Tung, Roderick
AU - Wang, Xunzhang
AU - Jiang, Chenyang
N1 - Funding Information:
This work was supported by the Investigator-Initiated Study Program of Biosense Webster, Inc. (Diamond Bar, California, USA).
Publisher Copyright:
Copyright © 2021 The Chinese Medical Association, published by Wolters Kluwer Health, Inc.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
KW - Atrial fibrillation
KW - Catheter ablation
KW - Intracardiac echocardiography
KW - Radiofrequency ablation
UR - http://www.scopus.com/inward/record.url?scp=85146382120&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85146382120&partnerID=8YFLogxK
U2 - 10.1097/CD9.0000000000000032
DO - 10.1097/CD9.0000000000000032
M3 - Article
AN - SCOPUS:85146382120
SN - 2096-952X
VL - 1
SP - 228
EP - 232
JO - Cardiology Discovery
JF - Cardiology Discovery
IS - 4
ER -