NCT00916435已完成不适用
Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 2
- 主要终点
- sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
研究概览
简要总结
The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:
- to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
- to predict progression of heart failure in patients with ICD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •history of acute MI at least 4 weeks old
- •non-ischemic LV dysfunction for at least 9 months
- •who have an EF < or = to 35%
- •who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
- •undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD
排除标准
- •inability or unwillingness to provide valid informed consent
- •pregnancy
- •any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment
结局指标
主要结局
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
时间窗: from enrollment up to 72 months
次要结局
- Composite heart failure outcome (HF hospitalization, HF death, heart transplant)(from enrollment up to 72 months)
- All-cause mortality(from enrollment up to 72 months)
研究者
Larisa Tereshchenko
Instructor of Medicine
Johns Hopkins University
研究点 (2)
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