Clinical trial NCT04723355: A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Instituto Dante Pazzanese de Cardiologia
name: Quoretech
First posted: 2021-01-25
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of Cardiac Arrhythmias
timeFrame: 24 hours
Secondary outcomes:
measure: Detection of Atrial Fibrillation or Atrial Flutter
timeFrame: 24 hours
measure: Detection of Supraventricular Tachycardia
timeFrame: 24 hours
measure: Detection of Ventricular Tachycardia
timeFrame: 24 hours
measure: Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation
timeFrame: 24 hours
measure: Detection of Atrioventricular Block
timeFrame: 24 hours
measure: Detection of Heart Beat Pauses
timeFrame: 24 hours
measure: Duration of the Holter Exam
timeFrame: 24 hours
measure: Mean Heart Rate
timeFrame: 24 hours
measure: Maximum Heart Rate
timeFrame: 24 hours
measure: Minimum Heart Rate
timeFrame: 24 hours
measure: Atrial Ectopic Heart Beats
timeFrame: 24 hours
measure: Ventricular Ectopic Heart Beats
timeFrame: 24 hours
measure: Episodes of Ventricular Tachycardia
timeFrame: 24 hours
measure: Episodes of Supraventricular Tachycardia
timeFrame: 24 hours
measure: Episodes of Heart Beat Pauses
timeFrame: 24 hours
measure: Holter System Convenience of Use
timeFrame: 24 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Karla Santo, PhD
role: STUDY_DIRECTOR
References: