Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 15
- 主要终点
- 12-lead ECG
研究概览
简要总结
A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent reason for visits to the emergency department. Currently, in the majority of cases, immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be effective, safe and more cost-effective than current standard of care and could lead to a higher quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECG with atrial fibrillation at the emergency department
- •Heart rate > 70bpm
- •Symptoms most probable due to atrial fibrillation
- •Duration of symptoms < 36 hours
- •> 18 years of age
- •Able and willing to sign informed consent
- •Able and willing to use MyDiagnostick
排除标准
- •Signs of myocardial infarction on ECG
- •Hemodynamic instability (systolic blood pressure < 100mm Hg, heart rate > 170 bpm)
- •Presence of pre-excitation syndrome
- •History of Sick Sinus Syndrome
- •History of unexplained syncope
- •History of persistent AF (episode of AF lasting more than 48 hours)
- •Acute heart failure
- •Currently enrolled in another clinical trial
- •Deemed unsuitable for participation by attending physician
研究组 & 干预措施
Standard Care
Pharmacological cardioversion and/or electrical cardioversion
干预措施: Pharmacological cardioversion - Flecainide (Drug)
Standard Care
Pharmacological cardioversion and/or electrical cardioversion
干预措施: Electrical cardioversion (Procedure)
Standard Care
Pharmacological cardioversion and/or electrical cardioversion
干预措施: Pharmacological cardioversion - Amiodarone (Drug)
Wait-and-see Approach
Rate control drugs only (metoprolol, verapamil or digoxin)
干预措施: Metoprolol (Drug)
Wait-and-see Approach
Rate control drugs only (metoprolol, verapamil or digoxin)
干预措施: Verapamil (Drug)
Wait-and-see Approach
Rate control drugs only (metoprolol, verapamil or digoxin)
干预措施: Digoxin (Drug)
结局指标
主要结局
12-lead ECG
时间窗: 4 weeks
Presence of sinus rhythm on ECG
次要结局
- Quality of life (SF-36)(Baseline, 4 weeks, 6 months, 12 months)
- One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events(One year)
- Time to first recurrence of Atrial Fibrillation(1 month)
- Total health care and societal costs(1 year)
- Quality of Life (AFEQT)(Baseline, 4 weeks, 6 months, 12 months)
- Time to conversion to sinus rhythm (Holter monitor)(48 hours)