Ambulatory Leadless Electrocardiogram Recorder Trial (ALERT Feasibility)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- HeartWatch arrhythmia event characterization accuracy
研究概览
简要总结
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question[s] it aims to answer are:
- Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices?
- Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.
详细描述
Two general types of consumer products are used to monitor patients with or at risk of heart rhythm disorders. Most estimate heart rhythm using blood flow (photoplethysmography) alone or in combination with activity sensors (accelerometer). These methods are not reliable in detecting heart rhythm abnormalities. Other methods record an ECG when the patient has symptoms. These devices are useful, but require the wearer to recognize their symptoms, attach the device and rest quietly to obtain an ECG recording of reasonable quality. The user then needs to send that information to a healthcare provider to verify. Hence, these consumer-based technologies are far from ideal. However, the diagnostic accuracy of single-lead ECG via wearable medical devices is excellent and, likely superior to a family physician's interpretation of a 12-lead ECG.3 High-quality ECG data from wearable devices that can unequivocally document AF can expedite its detection, allowing prompt diagnosis and appropriate prescription of antithrombotic and other therapies.
The HeartWatch arm band is designed to provide non-invasive, continuous single lead ECG data, irrespective of activity, the environment, and other factors. It continuously records ECG data for subsequent, offline analysis. The HeartWatch allows the user to note (flag) any symptoms they experience (e.g., palpitations, light-headedness, fainting, etc…) to allow for symptom-rhythm correlation and subsequent review by a physician. The HeartWatch displays all the elements of an ECG signal (i.e., PQRST) to facilitate diagnoses by physicians and is comparable to lead I of a traditional ECG system.
The HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms.
The primary purpose of the study is to compare the interpretability of all tagged and all non-normal clinically significant arrhythmia events and the detection of QRS complexes by the HeartWatch, an upper armbased, ambulatory, single lead ECG collection tool, vs. conventional Event Recorder or Holter monitor reference 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
- 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 an Event Recorder or Holter
- •Able to follow the protocol
- •Provision of written-informed consent
- •No functional implantable pacemaker or defibrillator
- •Left bicep circumference > 22 cm and < 45 cm
排除标准
- •Known allergy to any component of the Event Recorder
- •Known allergy to any component of the Holter monitor
- •Known allergy to any component of the HeartWatch
- •Dextrocardia
- •Implanted functional Pacemaker of Defibrillator
- •Left bicep circumference < 22 cm
- •Left bicep circumference > 45 cm
研究组 & 干预措施
HeartWatch vs. Event Recorder
All patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Event Recorder) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions.
干预措施: HeartWatch (Device)
HeartWatch vs. Holter
All patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Holter) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions.
干预措施: HeartWatch (Device)
结局指标
主要结局
HeartWatch arrhythmia event characterization accuracy
时间窗: Events will be assessed for the duration of time each participants wears the HeartWatch and holter/event recorder, up to 48 hours.
An arrhythmia diagnosis will be applied to all patient-tagged (symptomatic) events (HeartWatch, Event Recorder, and Holter) and all abnormal significant rhythm auto-triggered events (HeartWatch and Event Recorder) and recorded events (HeartWatch and Holter). For the HeartWatch to be considered comparable to the Holter and Event Recorder, the accuracy of the HeartWatch to categorize the correct arrhythmia must be \> 85% of the combined Holter and Event Recorder data.
HeartWatch recording accuracy of QRS complexes
时间窗: QRS complexes will be assessed for the duration of time each participants wears the HeartWatch and the holter monitor up to 48 hours.
To be considered comparable to the Holter, the HeartWatch must detect \> 90% of the QRS complexes recorded on the Holter lead I reference ECG signal
次要结局
- Does the HeartWatch differ from the Event Recorder and Holter monitor in terms of adverse events?(Events will be assessed up to 48 hours of the patient wearing the HeartWatch.)
- Evaluate if the HeartWatch will be similarly preferred to the Event Recorder and Holter monitor.(Up to 48 hours)
- The 10-minute averaged and paired PR/QRS intervals from the HeartWatch will be within 20 msec of the 10-minute averaged PR/QRS intervals from lead I of the Holter for at the same time points(Up to 48 hours.)
- the 10-minute averaged and paired QT intervals from the HeartWatch will be within 40 msec of the 10-minute averaged QT intervals from lead I of the Holter.(Up to 48 hours.)