PDF(Pubmed)
Abstract：
UNASSIGNED: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy.
UNASSIGNED: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF.
UNASSIGNED: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients.
UNASSIGNED: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes.
UNASSIGNED: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.
UNASSIGNED: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF.
UNASSIGNED: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients.
UNASSIGNED: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes.
UNASSIGNED: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.
摘要：
■单发装置越来越多地用于心房颤动（AF）中的肺静脉隔离（PVI）。北极前线冷冻球囊是最常用的单发技术。最近开发的新型脉冲场消融（PFA）装置（FARAPULSE）已被引入，旨在提高手术安全性和有效性。
■这项研究将比较新型FARAPULSEPFA装置和ArcticFront冷冻球囊用于有症状的阵发性房颤患者的首次PVI。
■单发冠军是一个多中心，由独立的临床事件委员会进行盲法终点判定的随机对照试验.总的来说,210例接受PVI的阵发性房颤患者在PFA和冷冻球囊消融之间以1：1的比例随机分配。在所有患者中进行使用可植入心脏监测器的连续心律监测。
■主要终点是指在消融后91天和365天内由植入式心脏监护仪确定的任何房性快速性心律失常(房颤和/或有组织的房性快速性心律失常)首次复发时间≥120秒。复合手术安全终点包括需要引流的心脏填塞,持续性膈神经麻痹,需要干预的血管并发症，中风/短暂性脑缺血发作，心房食管瘘,以及在手术期间或手术后30天内发生的死亡。关键次要终点包括(1)消融术后第1天高敏肌钙蛋白增加,（2）消融后三维电解剖标测分析（每个研究组前25名患者），（3）AF负担，（4）生活质量的变化。
■单发CHAMPION将使用新型FRAPulsePFA评估PVI对有症状阵发性房颤患者的疗效和安全性。
■这项研究将比较新型FARAPULSEPFA装置和ArcticFront冷冻球囊用于有症状的阵发性房颤患者的首次PVI。
■单发冠军是一个多中心，由独立的临床事件委员会进行盲法终点判定的随机对照试验.总的来说,210例接受PVI的阵发性房颤患者在PFA和冷冻球囊消融之间以1：1的比例随机分配。在所有患者中进行使用可植入心脏监测器的连续心律监测。
■主要终点是指在消融后91天和365天内由植入式心脏监护仪确定的任何房性快速性心律失常(房颤和/或有组织的房性快速性心律失常)首次复发时间≥120秒。复合手术安全终点包括需要引流的心脏填塞,持续性膈神经麻痹,需要干预的血管并发症，中风/短暂性脑缺血发作，心房食管瘘,以及在手术期间或手术后30天内发生的死亡。关键次要终点包括(1)消融术后第1天高敏肌钙蛋白增加,（2）消融后三维电解剖标测分析（每个研究组前25名患者），（3）AF负担，（4）生活质量的变化。
■单发CHAMPION将使用新型FRAPulsePFA评估PVI对有症状阵发性房颤患者的疗效和安全性。
