NCT00345592已完成4 期
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
研究概览
简要总结
Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.
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
- •chronic symptomatic HF despite stable, optimal drug therapy
- •indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
- •patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities
排除标准
- •Chronic atrial fibrillation
- •Valvular disease
- •patients who underwent or are planned for ablation of atrial fibrillation
- •cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
- •preexisting unipolar pacemaker
结局指标
主要结局
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
时间窗: 3 years from randomization (39 months total)
次要结局
未报告次要终点
研究者
研究点 (2)
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