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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: An innovative 3-lead wireless water resistant Holter device; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Instituto Dante Pazzanese de Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Instituto Dante Pazzanese de Cardiologia; Quoretech
• Investigators: Study Director: Karla Santo, PhD, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 40422220.1.0000.5462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will be shared upon review of a request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No