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Abstract：
BACKGROUND: Pulmonary 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: This 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.
BACKGROUND: The 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.
BACKGROUND: ChiCTR2200067081.
METHODS: This 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.
BACKGROUND: The 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.
BACKGROUND: ChiCTR2200067081.
摘要：
背景：肺静脉隔离（PVI）是心房颤动（AF）射频（RF）消融的基石。然而,单一消融策略并不总能在所有持续性房颤患者中达到预期的治疗效果,不同的临床特征需要个性化的策略。
方法：本研究旨在通过比较PVI和BCXL的疗效来确定持续性房颤的最佳导管消融策略（BC：环绕肺静脉隔离的大圆；XL：基于左心房基质的不固定线数）。BCXL-AF研究（临床试验编号：ChiCTR2200067081)被设计为前瞻性的，随机化，并行控制，单盲临床试验。总的来说,以1:1的比例将400例持续性房颤患者随机分为仅PVI和BCXL个体化消融组。随机分配到个体化消融组的患者将根据其临床状况使用由分层确定的实际消融方法进一步分类为风险分层。从出院到24个月大进行了7次术后访视。主要观察终点将是房性快速性心律失常的发生率（包括房颤，单次消融术后3个月的空白期未使用抗心律失常药物，持续时间≥30s）的房扑和房性心动过速。BCXL-AF研究将评估持续性AF射频消融的最佳方法，并评估个性化射频消融策略在降低AF复发率方面的有效性。
背景：回顾了研究方案，并获得陆军医科大学人类伦理委员会的伦理批准（批准号：2022-484-01）。所有参与者均提供书面知情同意书。这项研究是根据《赫尔辛基宣言》及其修正案的原则进行的。这项研究的结果将通过手稿出版物和会议演示文稿进行传播。
背景：ChiCTR2200067081。
方法：本研究旨在通过比较PVI和BCXL的疗效来确定持续性房颤的最佳导管消融策略（BC：环绕肺静脉隔离的大圆；XL：基于左心房基质的不固定线数）。BCXL-AF研究（临床试验编号：ChiCTR2200067081)被设计为前瞻性的，随机化，并行控制，单盲临床试验。总的来说,以1:1的比例将400例持续性房颤患者随机分为仅PVI和BCXL个体化消融组。随机分配到个体化消融组的患者将根据其临床状况使用由分层确定的实际消融方法进一步分类为风险分层。从出院到24个月大进行了7次术后访视。主要观察终点将是房性快速性心律失常的发生率（包括房颤，单次消融术后3个月的空白期未使用抗心律失常药物，持续时间≥30s）的房扑和房性心动过速。BCXL-AF研究将评估持续性AF射频消融的最佳方法，并评估个性化射频消融策略在降低AF复发率方面的有效性。
背景：回顾了研究方案，并获得陆军医科大学人类伦理委员会的伦理批准（批准号：2022-484-01）。所有参与者均提供书面知情同意书。这项研究是根据《赫尔辛基宣言》及其修正案的原则进行的。这项研究的结果将通过手稿出版物和会议演示文稿进行传播。
背景：ChiCTR2200067081。
