Evaluation of the effectiveness and safety of a novel substrate-based radiofrequency ablation for persistent atrial fibrillation: a prospective, randomised, parallel-controlled, single-blinded study protocol

• Published in: BMJ open Vol. 14; no. 2; p. e080539
• Main Authors: Yang, Jie, Song, Yuanbin, Bian, Shizhu, Zhang, Bo, Zhang, Yi, Wang, Xia, Cheng, Li, Fan, Yu, Liu, Changsong, Tan, Hu
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 27.02.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Ablation; Antiarrhythmics; Atrial Fibrillation - etiology; Cardiac arrhythmia; cardiology; Cardiovascular disease; Cardiovascular Medicine; Catheter Ablation - methods; Catheters; Chronic obstructive pulmonary disease; coronary intervention; Coronary vessels; Heart Atria; Hospitals; Humans; interventional radiology; Patients; Prospective Studies; Pulmonary Veins - surgery; randomized controlled trial; Randomized Controlled Trials as Topic; Recurrence; Sinuses; Treatment Outcome; Vein & artery diseases; coronary intervention; cardiovascular disease; interventional radiology; cardiology; randomized controlled trial
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-080539

IntroductionPulmonary vein isolation (PVI) is the cornerstone of radiofrequency (RF) ablation for atrial fibrillation (AF). However, a single ablation strategy does not always achieve the desired therapeutic effect in all patients with persistent AF, and individualised strategies are required for different clinical characteristics.Methods and analysisThis study aimed to determine the optimal catheter ablation strategy for persistent AF by comparing the efficacy of PVI and BCXL (BC: big circles encircling pulmonary vein isolation; XL: unfixed number of lines based on the left atrial substrate). The BCXL-AF study (clinical trial no. ChiCTR2200067081) was designed as a prospective, randomised, parallel-controlled, single-blinded clinical trial. Overall, 400 patients with persistent AF were randomised in a 1:1 ratio into PVI-only and BCXL-individualised ablation groups. Patients randomised to the individualised ablation group will be further categorised into risk strata according to their clinical condition using the actual ablation method determined by the strata. Seven postoperative visits were conducted from discharge to 24 months of age. The primary observation endpoint will be the incidence of atrial tachyarrhythmia (including AF, atrial flutter and atrial tachycardia with a duration of ≥30 s) without using antiarrhythmic drugs after a blank period of 3 months following a single ablation procedure. The BCXL-AF study will assess an optimal approach for persistent AF RF ablation and evaluate the effectiveness of individualised RF ablation strategies in reducing the recurrence rate of AF.Ethics and disseminationThe study protocol was reviewed, and ethical approval was obtained from the Army Medical University Human Ethics Committee (approval number: 2022-484-01). All the participants provided written informed consent. This study was conducted according to the principles of the Declaration of Helsinki and its amendments. The results of this study will be disseminated through manuscript publication and conference presentations.Trial registration numberChiCTR2200067081.