NCT00387803已完成2 期
VENTAK CHF/CONTAK CD Biventricular Pacing Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 2
- 主要终点
- Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
研究概览
简要总结
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
详细描述
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.
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
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure
- •Left ventricular ejection fraction <= 35%
- •QRS width >= 120 ms
- •Indicated for an implantable cardioverter defibrillator
排除标准
- •Indicated for a pacemaker
- •Atrial tachyarrhythmias
结局指标
主要结局
Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
次要结局
- Peak VO2
- NYHA Class
- Six minute walk distance
- Quality of life
- Echocardiographic measures
研究者
研究点 (2)
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