NCT04292405终止不适用
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CABs comparison
研究概览
简要总结
Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.
详细描述
Single arm, prospective, non significant risk device study to evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) compared with the CABs data simultaneously recorded by an acoustic cardiography recorder, the AUDICOR AM device.
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
- •18 years of age or older
- •heart failure or a history of heart failure
- •ischemic or non-ischemic cardiomyopathy
- •ejection Fraction less than or equal to 40% as measured within the last 6 months
排除标准
- •implanted left ventricular assist device
- •pacemaker dependency
- •currently hospitalized
- •atrial fibrillation on their last ECG or having an irregularly irregular pulse
结局指标
主要结局
CABs comparison
时间窗: 2 hours
Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared
次要结局
未报告次要终点
研究者
研究点 (1)
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