Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- QRS signal detection
研究概览
简要总结
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.
详细描述
Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 22 years of age at time of consent
- •Clinically indicated for a Holter monitor test
- •Able to wear the HeartWatch on the left bicep for the study duration
- •Able to follow the protocol
- •No functional implantable pacemaker or defibrillator
- •Left bicep circumference >/= 22 cm and </= 45 cm
- •Provision of written-informed consent
排除标准
- •Known allergy to any component of the Holter monitor
- •Known allergy to any component of the HeartWatch
- •Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
- •Dextrocardia
- •Implanted functional Pacemaker or Defibrillator
- •Left bicep circumference < 22 cm
- •Left bicep circumference < 45 cm
研究组 & 干预措施
Active device engagement
All subjects will wear either the Holter monitor and the HeartWatch.
干预措施: HeartWatch (Device)
结局指标
主要结局
QRS signal detection
时间窗: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours
Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal
次要结局
- ECG PR interval assessment(For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).)
- ECG QRS interval assessment(For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).)
- ECG strip evaluation(For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).)
- ECG interval assessment(For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).)