Maurhofer Jens, Kueffer Thomas, Knecht Sven, Thalmann Gregor, Badertscher Patrick, Kozhuharov Nikola, Krisai Philipp, Jufer Corinne, Iqbal Salik Ur Rehman, Heg Dik, Servatius Helge, Tanner Hildegard, Kühne Michael, Roten Laurent, Sticherling Christian, Reichlin Tobias
Department of Cardiology, Inselspital - University Hospital Bern, University of Bern, Bern, Switzerland.
Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
Heart Rhythm O2. 2024 Jun 3;5(7):460-467. doi: 10.1016/j.hroo.2024.05.008. eCollection 2024 Jul.
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.
This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF.
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.
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.
SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.
一次性使用的设备越来越多地用于心房颤动（AF）的肺静脉隔离（PVI）。北极星冷冻球囊是最常用的一次性技术。最近推出了一种新开发的新型脉冲场消融（PFA）设备（FARAPULSE），旨在提高手术安全性和有效性。
本研究将比较新型FARAPULSE PFA设备和北极星冷冻球囊用于有症状阵发性AF患者的首次PVI。
单射冠军是一项多中心、随机对照试验，由独立临床事件委员会进行盲法终点判定。总体而言，210例接受PVI的阵发性AF患者在PFA和冷冻球囊消融之间按1:1随机分组。所有患者均使用植入式心脏监测器进行连续心律监测。
主要终点是首次出现任何持续≥120秒的房性快速性心律失常（AF和/或有组织的房性快速性心律失常）的时间，并由植入式心脏监测器在消融后91天和365天内确定。综合手术安全终点包括需要引流的心包填塞、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）消融后第1天高敏肌钙蛋白升高；（2）消融后三维电解剖标测分析（每个研究组前25例患者）；（3）AF负荷；（4）生活质量变化。
单射冠军将评估使用新型FARAPULSE PFA对有症状阵发性AF患者进行PVI的疗效和安全性。
