NCT04723355

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-26
• Primary completion: 2021-11-16
• Completion: 2021-11-16
• First posted: 2021-01-25
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

1 site across 1 country: Brazil