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NCT Number: NCT04723355

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

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

An innovative 3-lead wireless water resistant Holter device

Device

The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.

A conventional device

Device

The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.

Primary outcomes

  1. Detection of Cardiac Arrhythmias

    Time frame: 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)

Secondary outcomes

  1. Detection of Atrial Fibrillation or Atrial Flutter

    Time frame: 24 hours

    Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors

  2. Detection of Supraventricular Tachycardia

    Time frame: 24 hours

    Number of patients with 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) detected in both Holter monitors

  3. Detection of Ventricular Tachycardia

    Time frame: 24 hours

    Number of patients with ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation) detected in both Holter monitors

  4. Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation

    Time frame: 24 hours

    Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors

  5. Detection of Atrioventricular Block

    Time frame: 24 hours

    Number of patients with atrioventricular 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) detected in both Holter monitors

  6. Detection of Heart Beat Pauses

    Time frame: 24 hours

    Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors

  7. Duration of the Holter Exam

    Time frame: 24 hours

    Duration of the Holter exam in both Holter monitors

  8. Mean Heart Rate

    Time frame: 24 hours

    Mean heart rate measured in both Holter monitors

  9. Maximum Heart Rate

    Time frame: 24 hours

    Maximum heart rate measured in both Holter monitors

  10. Minimum Heart Rate

    Time frame: 24 hours

    Minimum heart rate measured in both Holter monitors

  11. Atrial Ectopic Heart Beats

    Time frame: 24 hours

    Total number of atrial ectopic heart beats measured in both Holter monitors

  12. Ventricular Ectopic Heart Beats

    Time frame: 24 hours

    Total number of ventricular ectopic heart beats measured in both Holter monitors

  13. Episodes of Ventricular Tachycardia

    Time frame: 24 hours

    Total number of ventricular tachycardia episodes detected in both Holter monitors

  14. Episodes of Supraventricular Tachycardia

    Time frame: 24 hours

    Total number of supraventricular tachycardia episodes detected in both Holter monitors

  15. Episodes of Heart Beat Pauses

    Time frame: 24 hours

    Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors

  16. Holter System Convenience of Use

    Time frame: 24 hours

    Number of Participants Reporting the convenience of use of the Holter systems

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Instituto Dante Pazzanese de Cardiologia
  • Quoretech

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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