A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: An innovative 3-lead wireless water resistant Holter device
* Device: A conventional device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Refusal to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Holter device<br>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. | Device: An innovative 3-lead wireless water resistant Holter device<br>* The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.<br>Device: A conventional device<br>* The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of cardiac arrhythmias | Number of patients with cardiac arrhythmias detected in both Holter monitors, including a) atrial fibrillation or atrial flutter; b) supraventricular tachycardia (≥ 3 beats); c) ventricular tachycardia (≥ 3 beats); d) polymorphic ventricular tachycardia or ventricular fibrillation; e) atrioventricular (AV) block (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) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of atrial fibrillation or atrial flutter | Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors | 24 hours | 
| Detection of supraventricular tachycardia | Number of patients with supraventricular tachycardia (≥ 3 beats) detected in both Holter monitors | 24 hours | 
| Detection of ventricular tachycardia | Number of patients with ventricular tachycardia (≥ 3 beats) detected in both Holter monitors | 24 hours | 
| Detection of polymorphic ventricular tachycardia or ventricular fibrillation | Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors | 24 hours | 
| Detection of atrioventricular block | Number of patients with atrioventricular block, including 2nd degree AV block Mobitz type I and II, AV block 2:1 or complete AV block, detected in both Holter monitors | 24 hours | 
| Detection of heart beat pauses | Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors | 24 hours | 
| Duration of the Holter exam | Duration of the Holter exam in both Holter monitors | 24 hours | 
| Medium heart rate | Medium heart rate measured in both Holter monitors | 24 hours | 
| Maximum heart rate | Maximum heart rate measured in both Holter monitors | 24 hours | 
| Minimum heart rate | Minimum heart rate measured in both Holter monitors | 24 hours | 
| Atrial ectopic heart beats | Total number of atrial ectopic heart beats measured in both Holter monitors | 24 hours | 
| Ventricular ectopic heart beats | Total number of ventricular ectopic heart beats measured in both Holter monitors | 24 hours | 
| Episodes of ventricular tachycardia | Total number of ventricular tachycardia episodes detected in both Holter monitors | 24 hours | 
| Episodes of supraventricular tachycardia | Total number of supraventricular tachycardia episodes detected in both Holter monitors | 24 hours | 
| Episodes of heart beat pauses | Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors | 24 hours | 
| Holter system convenience of use | Patient self-reported evaluation of convenience of using each of the Holter monitors | 24 hours |