A Comparative Study of the Findings of Dynamic Electrocardiography (Holter System) Using the an Innovative 3-lead Wireless Water Resistant Device and a Conventional Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Detection of Cardiac Arrhythmias
研究概览
简要总结
Holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias. Newer Holter monitors may provide some advantages over the more traditional ones. This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device.
详细描述
The 24-hour ambulatory electrocardiography, commonly known as Holter monitoring, is a diagnostic method to correlate clinical symptoms with cardiac arrhythmias. The Holter monitor records electrical signals from the heart using electrodes attached to the chest, which are connected via cables to a digital recorder. In addition to the device to record the cardiac electrical signals, the Holter system also has a software for review and analysis of the record. The software of the Holter system has an integrated automatic analysis process to detect different sorts of heart beats, rhythms, etc, which are then validated by a technician and a physician. The success of the automatic analysis depends of the quality of the captured electrical signals, which are dependent on the appropriate attachment of the electrodes/cables to the patient body. Therefore, inappropriately attached electrodes/cables can result in electromagnetic disturbance that can interfere with the ECG signal, resulting in a very noisy record that is hard to be analysed.
Newer Holter systems that eliminate the cables and attach the recorder directly to the electrodes positioned in the patient´s chest might reduce the electromagnetic disturbance in the ECG signal capture and, therefore, improve the quality of the exam.
This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any individual who has an indication of 24 hours Holter monitoring and is referred to the arrhythmia clinic of the Instituto Dante Pazzanese de Cardiologia
排除标准
- •Refusal to provide written informed consent
研究组 & 干预措施
Holter device
In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device.
干预措施: An innovative 3-lead wireless water resistant Holter device (Device)
Holter device
In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device.
干预措施: A conventional device (Device)
结局指标
主要结局
Detection of Cardiac Arrhythmias
时间窗: 24 hours
Number of patients with cardiac arrhythmias detected in both Holter monitors, including a) atrial fibrillation or atrial flutter; b) supraventricular tachycardia (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter); c) ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation); d) polymorphic ventricular tachycardia or ventricular fibrillation; e) atrioventricular (AV) block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 2nd degree AV block Mobitz type I and II, AV block 2:1 or complete AV block); or f) heart beat pauses (≥ 2,5 seconds)
次要结局
- Detection of Atrial Fibrillation or Atrial Flutter(24 hours)
- Detection of Supraventricular Tachycardia(24 hours)
- Detection of Ventricular Tachycardia(24 hours)
- Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation(24 hours)
- Detection of Atrioventricular Block(24 hours)
- Detection of Heart Beat Pauses(24 hours)
- Duration of the Holter Exam(24 hours)
- Mean Heart Rate(24 hours)
- Maximum Heart Rate(24 hours)
- Minimum Heart Rate(24 hours)
- Atrial Ectopic Heart Beats(24 hours)
- Ventricular Ectopic Heart Beats(24 hours)
- Episodes of Ventricular Tachycardia(24 hours)
- Episodes of Supraventricular Tachycardia(24 hours)
- Episodes of Heart Beat Pauses(24 hours)
- Holter System Convenience of Use(24 hours)