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

Cardiac Arrhythmia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723355
• Other study ID #: 40422220.1.0000.5462
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: November 16, 2021

Study information

• Verified date: February 2022
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Instituto Dante Pazzanese de Cardiologia, Quoretech

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection of atrial fibrillation or atrial flutter	Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors	24 hours
Secondary	Detection of supraventricular tachycardia	Number of patients with supraventricular tachycardia (= 3 beats) detected in both Holter monitors	24 hours
Secondary	Detection of ventricular tachycardia	Number of patients with ventricular tachycardia (= 3 beats) detected in both Holter monitors	24 hours
Secondary	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
Secondary	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
Secondary	Detection of heart beat pauses	Number of patients with heart beat pauses = 2.5 seconds detected in both Holter monitors	24 hours
Secondary	Duration of the Holter exam	Duration of the Holter exam in both Holter monitors	24 hours
Secondary	Medium heart rate	Medium heart rate measured in both Holter monitors	24 hours
Secondary	Maximum heart rate	Maximum heart rate measured in both Holter monitors	24 hours
Secondary	Minimum heart rate	Minimum heart rate measured in both Holter monitors	24 hours
Secondary	Atrial ectopic heart beats	Total number of atrial ectopic heart beats measured in both Holter monitors	24 hours
Secondary	Ventricular ectopic heart beats	Total number of ventricular ectopic heart beats measured in both Holter monitors	24 hours
Secondary	Episodes of ventricular tachycardia	Total number of ventricular tachycardia episodes detected in both Holter monitors	24 hours
Secondary	Episodes of supraventricular tachycardia	Total number of supraventricular tachycardia episodes detected in both Holter monitors	24 hours
Secondary	Episodes of heart beat pauses	Total number of heart beat pauses = 2.5 seconds detected in both Holter monitors	24 hours
Secondary	Holter system convenience of use	Patient self-reported evaluation of convenience of using each of the Holter monitors	24 hours