Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 20
- 主要终点
- Biometric Data Associations to Arrhythmias
研究概览
简要总结
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.
详细描述
The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who require monitoring for non-lethal cardiac arrhythmias
- •Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring
- •Subjects 21 years of age or older
排除标准
- •Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors
- •Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
- •Subjects currently hospitalized
- •Subjects with a skin condition preventing them from wearing the AMS device
- •Subjects who are non-ambulatory
- •Subjects who are self-reporting to be pregnant
- •Subjects participating in another study
结局指标
主要结局
Biometric Data Associations to Arrhythmias
时间窗: 30 days
MCT Data Sets
Biometric Data Associations to Subject-Reported Symptoms
时间窗: 30 days
MCT Data Sets
Biometric Data Associations to Subject Wellness
时间窗: 30 days
MCT Data Sets
次要结局
- Clinician Use of Biometric Data Associations to Subject-Reported Symptoms(30 days)
- Clinician Use of Biometric Data Associations to Arrhythmias(30 days)
- Clinician Use of Biometric Data Associations to Wellness Status of Subject(30 days)