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

Not Applicable

Completed

Conditions: Cardiac Arrhythmia

Interventions: Device: An innovative 3-lead wireless water resistant Holter device
Device: A conventional device

Registration Number: NCT04723355

Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 231

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Holter device	An innovative 3-lead wireless water resistant 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.
Holter device	A conventional 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.

Primary Outcome Measures

Name	Time	Method
Detection of Cardiac Arrhythmias	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 Outcome Measures

Name	Time	Method
Detection of Atrial Fibrillation or Atrial Flutter	24 hours	Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors
Detection of Supraventricular Tachycardia	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
Detection of Ventricular Tachycardia	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
Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation	24 hours	Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors
Detection of Atrioventricular Block	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
Detection of Heart Beat Pauses	24 hours	Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Duration of the Holter Exam	24 hours	Duration of the Holter exam in both Holter monitors
Mean Heart Rate	24 hours	Mean heart rate measured in both Holter monitors
Maximum Heart Rate	24 hours	Maximum heart rate measured in both Holter monitors
Minimum Heart Rate	24 hours	Minimum heart rate measured in both Holter monitors
Atrial Ectopic Heart Beats	24 hours	Total number of atrial ectopic heart beats measured in both Holter monitors
Ventricular Ectopic Heart Beats	24 hours	Total number of ventricular ectopic heart beats measured in both Holter monitors
Episodes of Ventricular Tachycardia	24 hours	Total number of ventricular tachycardia episodes detected in both Holter monitors
Episodes of Supraventricular Tachycardia	24 hours	Total number of supraventricular tachycardia episodes detected in both Holter monitors
Episodes of Heart Beat Pauses	24 hours	Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Holter System Convenience of Use	24 hours	Number of Participants Reporting the convenience of use of the Holter systems