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临床试验/NCT00933634
NCT00933634已完成不适用

Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial

Valduce Hospital1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
247
试验地点
1
主要终点
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm

研究概览

简要总结

The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of less than 48 hours' duration is still controversial. The investigators performed a controlled single-center trial to compare electrical and pharmacological (propafenone) cardioversion to restore the sinus rhythm in selected patients with acute atrial fibrillation.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • atrial fibrillation of less than 48 hours' duration.

排除标准

  • AF of more than 48 hours'
  • hemodynamic instability
  • acute onset atrial fibrillation due to acute coronary syndrome
  • electrolyte disturbances
  • hypothermia
  • untreated hyperthyroidism
  • use of antiarrhythmic drugs
  • high embolic risk
  • unclear duration of symptoms

研究组 & 干预措施

electrical cardioversion

Experimental

Patients were sedated with propofol and external cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula). Patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary.

干预措施: electrical cardioversion (Procedure)

propafenone

Active Comparator

Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.

干预措施: propafenone (Drug)

结局指标

主要结局

Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm

时间窗: during emergency department stay

次要结局

  • Number of adverse events related to electrical and pharmacological cardioversion(during emergency department stay)
  • recurrence of atrial fibrillation(within 2 months)

研究者

发起方
Valduce Hospital
申办方类型
Other

研究点 (1)

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