LifeVest Trends Validation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 21
- 主要终点
- Distance Traveled in Six Minute Walk Test
研究概览
简要总结
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).
详细描述
This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
- •Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
- •Ejection fraction of 35% or less at the start of WCD use
- •Anticipated to need a WCD for three months or more
- •At least 18 years of age (over the legal age of providing consent)
排除标准
- •Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
- •Need for an assistive device for ambulation (wheelchair, walker, or cane)
- •Use of a unipolar pacemaker
- •Physical or mental conditions that prevent interaction with or wearing of the device
- •Advanced directive prohibiting resuscitation
- •Pregnancy
结局指标
主要结局
Distance Traveled in Six Minute Walk Test
时间窗: Three months
Relationship of the step count and distance measure of the LifeVest walk test in heart failure patients as compared to distance measure of medically supervised 6-minute walk test. Accuracy of activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.
次要结局
- Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.(Up to 12-14 Weeks of WCD use)
- Compliance With Completing 6MWT Through a Wearable Defibrillator.(Up to 12-14 Weeks of WCD use)