跳至主要内容
临床试验/NCT06556667
NCT06556667招募中不适用

Comparison of Maximum Energy Shocks From Two Defibrillator Vendors MAX - SHOCK- A Randomized Controlled Clinical Trial

Ottawa Heart Institute Research Corporation1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2025年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
376
试验地点
1
主要终点
ECV success

研究概览

简要总结

Can Electrical Cardioversion (ECV) for AF be improved. It is the preferred method to restore sinus rhythm in patients with AF in whom a rhythm-control strategy is pursued.

Hypothesis:

ECV success rates will be greater with a biphasic defibrillator with maximum energy of 360J (® Physio-Control) compared to a biphasic defibrillator with maximum energy of 200J (® Zoll)

详细描述

Published estimates of ECV success using modern biphasic defibrillators vary considerably but most are limited by small sample sizes. Our pre-intervention ECV success rate of 91.8% was stable over >2.5 years and is comparable to a previous study from our institute11 and to recent estimates from moderately sized studies using contemporary technology. For instance, the Euro Heart Survey on AF reported an ECV success rate of 91% in 424 patients2 and the Biphasic Energy Selection for Transthoracic cardioversion of Atrial Fibrillation (BEST AF) trial reported 89% success in 380 patients.3 The variability in starting shock energy and shock energy escalation observed at our centre prior to implementing the OAFCP is also consistent with reported practices elsewhere. A recent survey of 57 European centres found that nearly two-thirds of hospitals started with a 100 J biphasic shock for AF whereas the remaining third started with 200 J.1 Considerable differences in electrode placement were also reported in this survey with 58.7% of centres using an anterolateral position and the remainder using an anteroposterior approach.1Our investigators and others have previously shown that physicians seldom apply sufficient force even when prompted to do so and even when using handheld paddles.10,16,17 ECV practices at our institute prior to implementing the OAFCP were therefore likely representative of those at most centres.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

participants will not know which defibrillator was used during their cardioversion.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age > 18 years.
  • Persistent atrial fibrillation.
  • Scheduled for elective cardioversion at UOHI
  • Patient is within the circle of care of UOHI Electrophysiology staff

排除标准

  • Known left-atrial appendage thrombus.
  • Contraindication to appropriate anticoagulation.
  • Patient is included in another randomized clinical trial.
  • Patient does not meet all of the above listed inclusion criteria.

研究组 & 干预措施

200J

Active Comparator

biphasic defibrillator with maximum energy of 200J (® Zoll)

干预措施: biphasic defibrillator with maximum energy of 200J (® Zoll) (Device)

360J

Active Comparator

biphasic defibrillator with maximum energy of 360J (® Physio-Control)

干预措施: biphasic defibrillator with maximum energy of 360J (® Physio-Control) (Device)

结局指标

主要结局

ECV success

时间窗: 2 seconds

ECV success defined as \>\_2 consecutive sinus beats, or captured atrial-paced beats in patients with implanted cardiac devices, after shock delivery

次要结局

  • First shock success(2 seconds)
  • sustained success(4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验