Southlake Regional Health Centre, Newmarket, Ontario, Canada.
J Cardiovasc Electrophysiol. 2011 May;22(5):541-7. doi: 10.1111/j.1540-8167.2010.01959.x. Epub 2010 Nov 18.
Adjuvant ablation of complex fractionated atrial electrograms (CFAE) in addition to pulmonary vein isolation (PVI) likely improves procedural outcome compared to PVI alone, particularly in patients with persistent atrial fibrillation (AF). However, CFAE regions can be extensive, occasionally requiring a large amount of extra ablation. Some CFAE regions may also represent passive wavefront collision and may not require ablation. Thus, there is interest in identifying more selective CFAE sites that are critical to AF perpetuation, minimizing the amount of adjuvant ablation that must be performed.
The SELECT AF study is a prospective, multicenter, randomized trial comparing a strategy of PVI plus generalized CFAE ablation versus a strategy of PVI plus selective CFAE ablation, focusing on regions of continuous electrical activity (CEA). The primary efficacy endpoint is freedom from atrial arrhythmia at 1 year and the primary safety endpoint is total radiofrequency (RF) delivery time per procedure.
Patients undergoing a first time ablation procedure for symptomatic persistent AF will be included. Patients with permanent AF or with left atrial size ≥55 mm will be excluded. Patients will all receive PVI at the time of their ablation, but will be randomized 1:1 to receive adjuvant CFAE ablation using the traditional "generalized" approach, or a "selective" approach targeting only CEA regions. Both strategies will be guided by automated mapping algorithms. This study will enroll a minimum of 80 evaluable subjects; 40 in each randomization group.
SELECT AF is a randomized trial in patients with persistent AF to evaluate the efficacy of selective versus generalized CFAE ablation in addition to traditional PVI.
与单纯肺静脉隔离（PVI）相比，在复杂碎裂心房电图（CFAE）区域进行辅助消融，可能会改善手术结果，尤其是在持续性心房颤动（AF）患者中。然而，CFAE 区域可能很广泛，偶尔需要进行大量额外的消融。一些 CFAE 区域也可能代表被动波前碰撞，可能不需要消融。因此，人们有兴趣识别对 AF 持续存在至关重要的更具选择性的 CFAE 部位，从而最大限度地减少必须进行的辅助消融量。
SELECT AF 研究是一项前瞻性、多中心、随机试验，比较了 PVI 加广泛 CFAE 消融策略与 PVI 加选择性 CFAE 消融策略，重点关注连续电活动（CEA）区域。主要疗效终点是 1 年时无房性心律失常，主要安全性终点是每例手术的总射频（RF）输送时间。
纳入接受首次消融治疗症状性持续性 AF 的患者。排除永久性 AF 或左心房大小≥55mm 的患者。所有患者在消融时均接受 PVI，但将以 1:1 的比例随机分为接受传统“广泛”方法的辅助 CFAE 消融，或仅针对 CEA 区域的“选择性”方法。两种策略均由自动绘图算法指导。该研究将至少纳入 80 名可评估患者；每组随机分组 40 名。
SELECT AF 是一项针对持续性 AF 患者的随机试验，旨在评估选择性与广泛 CFAE 消融联合传统 PVI 相比的疗效。
