Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 6
- 主要终点
- Efficacy: First shock success
研究概览
简要总结
Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important treatment to reduce symptoms and improve patient's quality-of-life. The treatment is performed by applying gel electrodes to the chest. Cardioversion is not always successful, and it is unknown which electrode-position provides the optimal efficacy.
This study aims to compare two electrode positions, which are in clinical use: Anterior-posterior (left front and left back) versus anterior-lateral (right front and left side of the chest).
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
- •Atrial fibrillation (documented on an ECG-12)
- •Able and willing to sign informed consent
- •Age ≥ 18 years
- •Anticoagulation according to guidelines (Patients with atrial fibrillation for >48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting the absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin).
排除标准
- •Implanted pacemaker and/or cardioverter defibrillator (ICD)
- •Prior enrollment in the trial
- •Hemodynamically unstable atrial fibrillation
- •Untreated hyperthyroidism
- •Known or suspected pregnancy
结局指标
主要结局
Efficacy: First shock success
时间窗: Immediately after first cardioversion attempt.
The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.
次要结局
- Safety: Number of participants with skin-discomfort, skin burns or itching(Two hours after cardioversion (at discharge))
- Efficacy: Successful cardioversion(One minute after cardioversion)
- Safety: Number of participants with arrhythmic events during and after cardioversion(Within 2 hours after cardioversion (until discharge))