Hospital Wearable Defibrillator Inpatient Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 8
- 主要终点
- Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
研究概览
简要总结
This study will obtain device-human interaction evaluations for the HWD1000 within the controlled environment of the hospital as well as establish that the safety profile is similar to outpatient wearable cardioverter-defibrillators use.
详细描述
A multi-center prospective study of hospitalized patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period, wearing the HWD1000 hospital wearable defibrillator in order to evaluate caregiver and patient interactions with the device. In addition, ECG signal quality will be reviewed to confirm the HWD1000 safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are:
- •Hospitalized patients having continuous independent ECG monitoring.
- •Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician.
- •Patient ≥18 years of age (over the legal age of providing consent).
排除标准
- •Patients with an active implantable cardioverter-defibrillator.
- •Patients with an active unipolar pacemaker.
- •Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician.
- •Patients having an advanced directive prohibiting resuscitation.
- •Patients having bandages or other clinical condition preventing the HWD use.
- •Patients unable to consent.
- •Patients having recently experienced an arrhythmic storm.
- •Patients prone to paroxysmal supraventricular tachycardia.
结局指标
主要结局
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
时间窗: 24 hours or longer
The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).
次要结局
未报告次要终点