Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA Trial).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Electrical cardioversion success
研究概览
简要总结
Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. In this prospective open-label randomized trial consecutive patients with AF and candidate to AF electrical cardioversion will be randomized to receive 100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.
详细描述
Open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 J) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (Age>18 years)
- •Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but < 12 months)
- •Informed Consent
排除标准
- •Atrial Flutter or other arrythmias
结局指标
主要结局
Electrical cardioversion success
时间窗: Day 1
次要结局
- Electrical cardioversion success(3 months)
- Complications rate(Day 1)
研究者
Massimo Imazio
MD
Maria Vittoria Hospital