Cardiac ArrhythmiaNCT04723355
A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System
A study testing An innovative 3-lead wireless water resistant Holter device and A conventional device in people with Cardiac Arrhythmia, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- An innovative 3-lead wireless water resistant Holter device and A conventional device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jan 2021to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- An innovative 3-lead wireless water resistant Holter device, A conventional device
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An innovative 3-lead wireless water resistant Holter deviceDevice
The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
A conventional deviceDevice
The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Holter device | Experimental | 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. Receives: Device: An innovative 3-lead wireless water resistant Holter device; Device: A conventional device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter); c) ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation); d) polymorphic ventricular tachycardia or ventricular fibrillation; e) atrioventricular (AV) block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 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)
Measured: 24 hours
Secondary outcomes (16)
Detection of Atrial Fibrillation or Atrial Flutter
Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors
Measured: 24 hours
Detection of Supraventricular Tachycardia
Number of patients with supraventricular tachycardia (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter) detected in both Holter monitors
Measured: 24 hours
Detection of Ventricular Tachycardia
Number of patients with ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation) detected in both Holter monitors
Measured: 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
Measured: 24 hours
Detection of Atrioventricular Block
Number of patients with atrioventricular block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 2nd degree AV block Mobitz type I and II, AV block 2:1 or complete AV block) detected in both Holter monitors
Measured: 24 hours
Detection of Heart Beat Pauses
Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Measured: 24 hours
Duration of the Holter Exam
Duration of the Holter exam in both Holter monitors
Measured: 24 hours
Mean Heart Rate
Mean heart rate measured in both Holter monitors
Measured: 24 hours
Maximum Heart Rate
Maximum heart rate measured in both Holter monitors
Measured: 24 hours
Minimum Heart Rate
Minimum heart rate measured in both Holter monitors
Measured: 24 hours
Atrial Ectopic Heart Beats
Total number of atrial ectopic heart beats measured in both Holter monitors
Measured: 24 hours
Ventricular Ectopic Heart Beats
Total number of ventricular ectopic heart beats measured in both Holter monitors
Measured: 24 hours
Episodes of Ventricular Tachycardia
Total number of ventricular tachycardia episodes detected in both Holter monitors
Measured: 24 hours
Episodes of Supraventricular Tachycardia
Total number of supraventricular tachycardia episodes detected in both Holter monitors
Measured: 24 hours
Episodes of Heart Beat Pauses
Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Measured: 24 hours
Holter System Convenience of Use
Number of Participants Reporting the convenience of use of the Holter systems
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start26 Jan 2021
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia, Quoretech
- Responsible party
- Sponsor
- Investigators
- Karla Santo, PhD, Study director, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723355
- Sponsor's protocol ID
- 40422220.1.0000.5462
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2021
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be shared upon review of a request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04723355
- Acronym / sponsor ID
- 40422220.1.0000.5462
- Conditions
- Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia, Quoretech
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holter device | Experimental | Device: An innovative 3-lead wireless water resistant Holter device, Device: A conventional deviceIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An innovative 3-lead wireless water resistant Holter deviceThe participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. | Device | Holter device |
| A conventional deviceThe participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours. | Device | Holter device |
Primary outcome
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 (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter); c) ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation); d) polymorphic ventricular tachycardia or ventricular fibrillation; e) atrioventricular (AV) block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 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)
16 secondary outcomes
Detection of Atrial Fibrillation or Atrial Flutter
Time frame: 24 hours
Detection of Supraventricular Tachycardia
Time frame: 24 hours
Detection of Ventricular Tachycardia
Time frame: 24 hours
Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation
Time frame: 24 hours
Detection of Atrioventricular Block
Time frame: 24 hours
Detection of Heart Beat Pauses
Time frame: 24 hours
Duration of the Holter Exam
Time frame: 24 hours
Mean Heart Rate
Time frame: 24 hours
Maximum Heart Rate
Time frame: 24 hours
Minimum Heart Rate
Time frame: 24 hours
Atrial Ectopic Heart Beats
Time frame: 24 hours
Ventricular Ectopic Heart Beats
Time frame: 24 hours
Episodes of Ventricular Tachycardia
Time frame: 24 hours
Episodes of Supraventricular Tachycardia
Time frame: 24 hours
Episodes of Heart Beat Pauses
Time frame: 24 hours
Holter System Convenience of Use
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will be shared upon review of a request.
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Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Santo, PhD study director
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An innovative 3-lead wireless water resistant Holter device and A conventional device in people with Cardiac Arrhythmia, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Cardiac Arrhythmias (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.