背景:利用低温热能的单次肺静脉隔离(PVI)是房颤(AF)患者的有效且安全的治疗方法。一种新颖的冷冻球囊系统,POLARx™,最近推出的。这项研究的目的是比较疗效,安全,和新型冷冻球囊系统之间的PVI的生物物理参数,POLARx™,和标准的冷冻球囊系统,北极前线前进Pro™(AFA-Pro),阵发性房颤患者。
方法:CONTROST-CRYO试验是一项前瞻性试验,多中心,开放标签,在7个大型心脏中心进行的随机对照研究.本研究得到了每个参与医院的中央伦理委员会或当地伦理委员会的批准,并已在UMIN临床试验注册中心(UMIN000049948)注册。该试验将以1:1的比例将200名接受PVI的阵发性房颤患者分配给POLARx™和AFA-Pro。主要终点是右下肺静脉的一次性急性成功率。第二个终点包括免于记录的心房颤动,房扑,或在手术后12个月没有抗心律失常药物的房性心动过速,免于重做程序,手术相关不良事件的发生率,冻结持续时间,以及每个PV应用期间的生物物理参数,总程序和透视时间,和PVI耐久性在重做程序。
结论:CONTROST-CRYO试验是一项前瞻性试验,多中心,旨在阐明疗效差异的随机研究,安全,在接受PVI的阵发性房颤患者中,POLARx™和AFA-Pro之间的生物物理参数。该试验的结果可能为选择最佳的冷冻球囊系统提供有价值的指示。
背景:UMIN000049948.
BACKGROUND: Single-shot pulmonary vein isolation (PVI) utilizing cryothermal energy is an effective and safe treatment for atrial fibrillation (AF) patients. A novel cryoballoon system, POLARx™, has been recently introduced. The aim of this study was to compare the efficacy, safety, and biophysical parameters of PVI between the novel cryoballoon system, POLARx™, and the standard cryoballoon system, Arctic Front Advance Pro™ (AFA-Pro), in patients with paroxysmal AF.
METHODS: The CONTRAST-CRYO trial is a prospective, multicenter, open-label, randomized controlled study performed at seven large cardiac centers. This study was approved by the central ethics committee or the local ethics committee of each participating hospital and has been registered at UMIN Clinical Trials Registry (UMIN000049948). The trial will assign 200 patients with paroxysmal AF undergoing PVI to POLARx™ and AFA-Pro in a 1:1 randomization. The primary endpoint is the one-shot acute success rate of the right inferior pulmonary vein. Second endpoints include freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia without antiarrhythmic drugs at 12 months after the procedure, freedom from re-do procedures, the incidence of procedure-related adverse events, freezing duration, and the biophysical parameters during applications for each PV, total procedure and fluoroscopy time, and PVI durability during re-do procedures.
CONCLUSIONS: The CONTRAST-CRYO trial is a prospective, multicenter, randomized study designed to elucidate the difference in the efficacy, safety, and biophysical parameters between POLARx™ and AFA-Pro in paroxysmal AF patients undergoing PVI. The findings from this trial may provide a valuable indication for selecting the optimal cryoballoon system.
BACKGROUND: UMIN000049948.