Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
研究概览
简要总结
To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.
详细描述
So far it is unknown if early or delayed cardioversion is most beneficial for patient outcome and which strategy is best to prevent recurrence of AF. The KONVERT-AF trial investigates if in acute symptomatic AF the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion. Primary endpoint is the time to the first recurrence of AF. The KONVERT-AF trial will be conducted as prospective, randomized, non-blinded multicentre study. It is planned to include 380 patients in 10-20 recruitment centres.
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
- •documented AF that began between 2 and 8 hrs before randomization
- •indication for electrical cardioversion.
- •age above 18 yrs
- •written informed consent
排除标准
- •AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery)
- •newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III
- •catheter ablation of AF within 3 months before randomization
- •pacemaker or icd
- •myocardial infarction within 3 months before randomization
- •urgent need to cardioversion of AF because of associated potentially dangerous symptoms such as chest pain, syncope, dyspnea
- •contraindications for therapy with vitamin k-antagonists
- •intracardial thrombus
- •primary indication for pharmacological cardioversion
- •in females: pregnancy, lactation period or no sufficient contraception within last 3 months