A comparative study of an innovative 3-lead wireless water-resistant Holter system and a conventional Holter system

Holter monitoring is one of the most widely used diagnostic methods for detecting cardiac arrhythmias. Newer Holter monitors may offer some advantages over more traditional ones. This study will compare the results of a Holter test using an innovative 3-lead wireless water-resistant device with a conventional device.

Condition or disease
Cardiac arrhythmia

Intervention/treatment
Device: An innovative 3-lead wireless water-resistant Holter device
Device: A conventional device

Internship
Not applicable

Detailed description:

24-hour ambulatory electrocardiography, commonly known as Holter monitoring, is a diagnostic method for correlating 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 for recording the heart's electrical signals, the Holter system also has software for reviewing and analyzing the recordings. The Holter system software has a built-in automatic analysis process to detect different types of heartbeats, rhythms, etc., which are then validated by a technician and a doctor. The success of the automatic analysis depends on the quality of the electrical signals captured, which depend on the electrodes/cables being properly attached to the patient's body. Therefore, improperly attached electrodes/cables can result in electromagnetic disturbances that can interfere with the ECG signal, resulting in a very noisy recording that is difficult to analyze.

Newer Holter systems, which do away with cables and attach the recorder directly to the electrodes positioned on the patient's chest, can reduce electromagnetic disturbance to the ECG signal and therefore improve the quality of the test.

Study design

This study will compare the results of a Holter test using an innovative 3-lead wireless water-resistant device with a conventional device.

Type of study: Interventional (Clinical Trial)

Actual registrations: 231 participants

Allocation: N/A

Intervention Model: Single Group Work

Masking: None (open label)

Main objective: diagnosis

Official title: A comparative study of the findings of dynamic electrocardiography (Holter system) using an innovative water-resistant 3-lead wireless device and a conventional device

Actual study start date: January 26, 2021

Actual primary completion date: November 16, 2021

Actual study completion date: November 16, 2021

Resource links provided by the National Library of Medicine
MedlinePlus related topics: Arrhythmia Drinking water
US FDA resources

Arms and Interventions

Arm
Experimental: Holter device
In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative water-resistant 3-lead wireless device and a conventional device.

Intervention/treatment
Device: An innovative 3-lead wireless water-resistant Holter device
The participant will wear 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 wear the innovative 3-lead wireless water-resistant Holter device simultaneously with the conventional Holter device for 24 hours.

Outcome measures

Primary outcome measures:

1. Detection of cardiac arrhythmias [ Deadline: 24 hours ]
   1. Number of patients with cardiac arrhythmias detected on 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) heartbeat pauses (≥ 2.5 seconds)

Secondary outcome measures:

1. Detection of atrial fibrillation or atrial flutter [ Deadline: 24 hours ]
   1. Number of patients with atrial fibrillation or atrial flutter detected on both Holter monitors
      
2. Detection of supraventricular tachycardia [ Deadline: 24 hours ]
   1. Number of patients with supraventricular tachycardia (≥ 3 beats) detected on both Holter monitors
      
3. Detection of ventricular tachycardia [ Deadline: 24 hours ]
   1. Number of patients with ventricular tachycardia (≥ 3 beats) detected on both Holter monitors
      
4. Detection of polymorphic ventricular tachycardia or ventricular fibrillation [ Deadline: 24 hours ]
   1. Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected on both Holter monitors
      
5. Detection of atrioventricular block [ Deadline: 24 hours ]
   1. Number of patients with atrioventricular block, including 2nd degree Mobitz type I and II AV block, 2:1 AV block or complete AV block, detected on both Holter monitors
      
6. Detection of heartbeat pauses [Deadline: 24 hours]
   1. Number of patients with heartbeat pauses ≥ 2.5 seconds detected on both Holter monitors
      
7. Holter test duration [ Time limit: 24 hours ]
   1. Duration of Holter test on both Holter monitors
      
8. Average heart rate [Time frame: 24 hours]
   1. Average heart rate measured on both Holter monitors
      
9. Maximum heart rate [Time limit: 24 hours]
   1. Maximum heart rate measured on both Holter monitors
      
10. Minimum heart rate [Time limit: 24 hours]
    1. Minimum heart rate measured on both Holter monitors
       
11. Atrial ectopic heartbeat [Timeframe: 24 hours]
    1. Total number of atrial ectopic heartbeats measured on both Holter monitors
       
12. Ventricular ectopic heartbeat [Timeframe: 24 hours]
    1. Total number of ventricular ectopic heartbeats measured on both Holter monitors
       
13. Episodes of ventricular tachycardia [Timeframe: 24 hours]
    1. Total number of ventricular tachycardia episodes detected on both Holter monitors
       
14. Episodes of supraventricular tachycardia [Timeframe: 24 hours]
    1. Total number of supraventricular tachycardia episodes detected on both Holter monitors
       
15. Episodes of pauses in the heartbeat [Period: 24 hours]
    1. Total number of heartbeat pauses ≥ 2.5 seconds detected on both Holter monitors
       
16. Convenience of using the Holter system [Deadline: 24 hours]
    1. Patient self-reported assessment of the convenience of using each of the Holter monitors

Election criteria

Information from the National Library of Medicine
Choosing to take part in a study is an important personal decision. Talk to your doctor and family or friends about the decision to take part in a study. To find out more about this study, you or your doctor can contact the study's research team via the contacts provided below.

Ages eligible for study: 18 years or older (adult, elderly)
Sexes eligible for study: all
Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:
Any individual who has an indication for a 24-hour Holter and is referred to the arrhythmia outpatient clinic at the Dante Pazzanese Institute of Cardiology.

Exclusion criteria:
Refusal to provide written informed consent

Contacts and Locations

Information from the National Library of Medicine
To find out more about this study, you or your doctor can contact the study research team using the contact information provided by the sponsor.

Look up this study by its ClinicalTrials.gov identifier (NCT number): NCT04723355

Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil

Sponsors and Collaborators
Hospital Israelita Albert Einstein
Instituto Dante Pazzanese de Cardiologia
Quoretech

Investigators
Study Director: Karla Santo, PhD Hospital Israelita Albert Einstein

For more information visit: https://classic.clinicaltrials.gov/ct2/show/study/NCT04723355