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

• ClinicalTrials.gov Identifier: NCT04723355
• Recruitment Status: Completed
• First Posted: January 25, 2021
• Last Update Posted: September 13, 2022
• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Instituto Dante Pazzanese de Cardiologia; Quoretech
• Information provided by (Responsible Party): Hospital Israelita Albert Einstein

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrhythmia	Device: An innovative 3-lead wireless water resistant Holter device; Device: A conventional device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 231 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: January 26, 2021
• Actual Primary Completion Date: November 16, 2021
• Actual Study Completion Date: November 16, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Detection of cardiac arrhythmias [ Time Frame: 24 hours ]
   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)

Secondary Outcome Measures :

1. Detection of atrial fibrillation or atrial flutter [ Time Frame: 24 hours ]
   Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors
2. Detection of supraventricular tachycardia [ Time Frame: 24 hours ]
   Number of patients with supraventricular tachycardia (≥ 3 beats) detected in both Holter monitors
3. Detection of ventricular tachycardia [ Time Frame: 24 hours ]
   Number of patients with ventricular tachycardia (≥ 3 beats) detected in both Holter monitors
4. Detection of polymorphic ventricular tachycardia or ventricular fibrillation [ Time Frame: 24 hours ]
   Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors
5. Detection of atrioventricular block [ Time Frame: 24 hours ]
   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
6. Detection of heart beat pauses [ Time Frame: 24 hours ]
   Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
7. Duration of the Holter exam [ Time Frame: 24 hours ]
   Duration of the Holter exam in both Holter monitors
8. Medium heart rate [ Time Frame: 24 hours ]
   Medium heart rate measured in both Holter monitors
9. Maximum heart rate [ Time Frame: 24 hours ]
   Maximum heart rate measured in both Holter monitors
10. Minimum heart rate [ Time Frame: 24 hours ]
    Minimum heart rate measured in both Holter monitors
11. Atrial ectopic heart beats [ Time Frame: 24 hours ]
    Total number of atrial ectopic heart beats measured in both Holter monitors
12. Ventricular ectopic heart beats [ Time Frame: 24 hours ]
    Total number of ventricular ectopic heart beats measured in both Holter monitors
13. Episodes of ventricular tachycardia [ Time Frame: 24 hours ]
    Total number of ventricular tachycardia episodes detected in both Holter monitors
14. Episodes of supraventricular tachycardia [ Time Frame: 24 hours ]
    Total number of supraventricular tachycardia episodes detected in both Holter monitors
15. Episodes of heart beat pauses [ Time Frame: 24 hours ]
    Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
16. Holter system convenience of use [ Time Frame: 24 hours ]
    Patient self-reported evaluation of convenience of using each of the Holter monitors

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

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

More Information

• Responsible Party: Hospital Israelita Albert Einstein
• ClinicalTrials.gov Identifier: NCT04723355
• Other Study ID Numbers: 40422220.1.0000.5462
• First Posted: January 25, 2021
• Last Update Posted: September 13, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes