NCT01448005终止不适用
Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 5
- 主要终点
- number of patients who experience sudden cardiac death
研究概览
简要总结
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.
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
- •Patients who have undergone CABG surgery during current hospitalization
- •Patients who have an ejection fraction ≤ 35% following the surgery.
- •Patients who have dilated cardiomyopathy or prior myocardial infarction.
- •Patients who are prescribed a wearable defibrillator following surgery.
- •Patient who are at least 18 years old.
排除标准
- •Patients who have an active ICD.
- •Patients who have an active unipolar pacemaker.
- •Patients having a chest circumference over 56 inches or under 26 inches.
- •Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
- •Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
- •Patients participating in another clinical study with mortality as the primary endpoint.
- •Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
- •Patients who have decided to forgo resuscitation.
结局指标
主要结局
number of patients who experience sudden cardiac death
时间窗: three months
次要结局
- number of patients who experience inappropriate shocks(three months)
- number of patients who experience sudden cardiac arrest(three months)
- hours per day of wearable defibrillator use(three months)
研究者
研究点 (5)
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