Cardiac Arrhythmia
Conditions
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.
Interventions
DEVICEAn 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.
DEVICEA conventional device
The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.
Sponsors
Instituto Dante Pazzanese de Cardiologia
Quoretech
Hospital Israelita Albert Einstein
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Cardiac Arrhythmias | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Supraventricular Tachycardia | 24 hours | 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 |
| Detection of Ventricular Tachycardia | 24 hours | 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 |
| Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation | 24 hours | Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors |
| Detection of Atrioventricular Block | 24 hours | 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 |
| Detection of Heart Beat Pauses | 24 hours | Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors |
| Duration of the Holter Exam | 24 hours | Duration of the Holter exam in both Holter monitors |
| Mean Heart Rate | 24 hours | Mean heart rate measured in both Holter monitors |
| Detection of Atrial Fibrillation or Atrial Flutter | 24 hours | Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors |
| Minimum Heart Rate | 24 hours | Minimum heart rate measured in both Holter monitors |
| Atrial Ectopic Heart Beats | 24 hours | Total number of atrial ectopic heart beats measured in both Holter monitors |
| Ventricular Ectopic Heart Beats | 24 hours | Total number of ventricular ectopic heart beats measured in both Holter monitors |
| Episodes of Ventricular Tachycardia | 24 hours | Total number of ventricular tachycardia episodes detected in both Holter monitors |
| Episodes of Supraventricular Tachycardia | 24 hours | Total number of supraventricular tachycardia episodes detected in both Holter monitors |
| Episodes of Heart Beat Pauses | 24 hours | Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors |
| Holter System Convenience of Use | 24 hours | Number of Participants Reporting the convenience of use of the Holter systems |
| Maximum Heart Rate | 24 hours | Maximum heart rate measured in both Holter monitors |
Countries
Brazil
Participant flow
Recruitment details
Individuals attending the study inclusion criteria were consecutively approached to participate in the study between 26 January 2021 and 16 November 2021 at the arrhythmia clinic of the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 179 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Errors in the informed consent form | 2 |
| Overall Study | Issues with leads off, substantial ECG signal artefacts, and ECG data upload errors | 50 |
Baseline characteristics
| Characteristic | Holter Device |
|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 13.9 |
| Body mass index | 27.6 kg/m^2 STANDARD_DEVIATION 4.8 |
| Chronic obstructive pulmonary disease Did not know | 1 Participants |
| Chronic obstructive pulmonary disease Missing | 50 Participants |
| Chronic obstructive pulmonary disease No | 117 Participants |
| Chronic obstructive pulmonary disease Yes | 11 Participants |
| Diabetes Did not know | 2 Participants |
| Diabetes Missing | 8 Participants |
| Diabetes No | 130 Participants |
| Diabetes Yes | 39 Participants |
| Heart failure Did not know | 2 Participants |
| Heart failure Missing | 10 Participants |
| Heart failure No | 81 Participants |
| Heart failure Yes | 86 Participants |
| Hypertension Missing | 8 Participants |
| Hypertension No | 48 Participants |
| Hypertension Yes | 123 Participants |
| Hypothyroidism Did not know | 3 Participants |
| Hypothyroidism Missing | 50 Participants |
| Hypothyroidism No | 106 Participants |
| Hypothyroidism Yes | 20 Participants |
| Level of education Complete postgraduate school | 2 Participants |
| Level of education Complete primary school | 61 Participants |
| Level of education Complete secondary school | 57 Participants |
| Level of education Complete technical school | 2 Participants |
| Level of education Complete undergraduate school | 26 Participants |
| Level of education Illiterate | 1 Participants |
| Level of education Incomplete primary school | 21 Participants |
| Level of education Incomplete undergraduate school | 9 Participants |
| Marital status Divorced | 19 Participants |
| Marital status Married | 115 Participants |
| Marital status Single | 30 Participants |
| Marital status Widowed | 15 Participants |
| Previous myocardial infarction Did not know | 1 Participants |
| Previous myocardial infarction Missing | 8 Participants |
| Previous myocardial infarction No | 128 Participants |
| Previous myocardial infarction Yes | 42 Participants |
| Previous stroke Did not know | 1 Participants |
| Previous stroke Missing | 50 Participants |
| Previous stroke No | 92 Participants |
| Previous stroke Yes | 36 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black | 29 Participants |
| Race/Ethnicity, Customized Race Mixed | 35 Participants |
| Race/Ethnicity, Customized Race White | 113 Participants |
| Region of Enrollment Brazil | 179 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 179 |
| other Total, other adverse events | 0 / 179 |
| serious Total, serious adverse events | 0 / 179 |
Outcome results
Primary
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)
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Cardiac Arrhythmias | Conventional Holter System | 104 Participants |
| Holter Device | Detection of Cardiac Arrhythmias | Innovative 3-lead Wireless Water Resistant Holter System | 107 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.81, 0.92]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.83, 0.95]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.72, 0.9]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.8, 0.93]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.76, 0.93]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [3.17, 8.58]
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0.06, 0.21]
Secondary
Atrial Ectopic Heart Beats
Total number of atrial ectopic heart beats measured in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Atrial Ectopic Heart Beats | Innovative 3-lead Wireless Water Resistant Holter System | 717.09 atrial ectopic heart beats in 24 hr | Standard Deviation 2323.94 |
| Holter Device | Atrial Ectopic Heart Beats | Conventional Holter System | 723.46 atrial ectopic heart beats in 24 hr | Standard Deviation 2223.27 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-1391.46, 1378.72]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.94, 0.96]
Secondary
Detection of Atrial Fibrillation or Atrial Flutter
Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Atrial Fibrillation or Atrial Flutter | Innovative 3-lead Wireless Water Resistant Holter System | 23 Participants |
| Holter Device | Detection of Atrial Fibrillation or Atrial Flutter | Conventional Holter System | 22 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.97, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.85, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.97, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.78, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.98, 1]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [22.25, 1107.61]
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0, 0]
Secondary
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
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Atrioventricular Block | Conventional Holter System | 4 Participants |
| Holter Device | Detection of Atrioventricular Block | Innovative 3-lead Wireless Water Resistant Holter System | 5 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.95, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.19, 0.99]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.96, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.15, 0.95]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.97, 1]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [14.8, 291.07]
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0.05, 1.38]
Secondary
Detection of Heart Beat Pauses
Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Heart Beat Pauses | Innovative 3-lead Wireless Water Resistant Holter System | 7 Participants |
| Holter Device | Detection of Heart Beat Pauses | Conventional Holter System | 11 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.94, 0.99]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.31, 0.89]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.98, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.59, 1]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.94, 0.99]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0.17, 0.79]
Secondary
Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation
Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation | Innovative 3-lead Wireless Water Resistant Holter System | 14 Participants |
| Holter Device | Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation | Conventional Holter System | 12 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.89, 0.96]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.28, 0.85]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.92, 0.98]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.23, 0.77]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.93, 0.99]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [5.84, 33.17]
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0.22, 0.85]
Secondary
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
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Supraventricular Tachycardia | Innovative 3-lead Wireless Water Resistant Holter System | 71 Participants |
| Holter Device | Detection of Supraventricular Tachycardia | Conventional Holter System | 71 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.79, 0.9]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.71, 0.9]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.8, 0.93]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.71, 0.9]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.8, 0.93]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [4.03, 11.43]
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0.13, 0.34]
Secondary
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
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Detection of Ventricular Tachycardia | Innovative 3-lead Wireless Water Resistant Holter System | 26 Participants |
| Holter Device | Detection of Ventricular Tachycardia | Conventional Holter System | 23 Participants |
Comparison: The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.95% CI: [0.88, 0.96]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.56, 0.93]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.9, 0.98]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.48, 0.86]
Comparison: Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.95% CI: [0.93, 0.99]
Comparison: We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [7.51, 30.99]
Comparison: Exploratory analyses of positive and negative likelihood ratios were also conducted.95% CI: [0.11, 0.5]
Secondary
Duration of the Holter Exam
Duration of the Holter exam in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Duration of the Holter Exam | Innovative 3-lead Wireless Water Resistant Holter System | 21.79 hours | Standard Deviation 1.4 |
| Holter Device | Duration of the Holter Exam | Conventional Holter System | 21.74 hours | Standard Deviation 1.95 |
Secondary
Episodes of Heart Beat Pauses
Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Episodes of Heart Beat Pauses | Innovative 3-lead Wireless Water Resistant Holter System | 1.74 heart beat pauses in 24hr | Standard Deviation 12.13 |
| Holter Device | Episodes of Heart Beat Pauses | Conventional Holter System | 1.84 heart beat pauses in 24hr | Standard Deviation 12.43 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-1.75, 1.56]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.997, 0.998]
Secondary
Episodes of Supraventricular Tachycardia
Total number of supraventricular tachycardia episodes detected in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Episodes of Supraventricular Tachycardia | Conventional Holter System | 6.37 supraventricular tachycardia episodes | Standard Deviation 41.1 |
| Holter Device | Episodes of Supraventricular Tachycardia | Innovative 3-lead Wireless Water Resistant Holter System | 5.71 supraventricular tachycardia episodes | Standard Deviation 38.59 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-13.38, 12.07]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.98, 0.99]
Secondary
Episodes of Ventricular Tachycardia
Total number of ventricular tachycardia episodes detected in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Episodes of Ventricular Tachycardia | Innovative 3-lead Wireless Water Resistant Holter System | 1.12 ventricular tachycardia episodes in 24hr | Standard Deviation 6.29 |
| Holter Device | Episodes of Ventricular Tachycardia | Conventional Holter System | 1.24 ventricular tachycardia episodes in 24hr | Standard Deviation 7.86 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-5.45, 5.2]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.91, 0.94]
Secondary
Holter System Convenience of Use
Number of Participants Reporting the convenience of use of the Holter systems
Time frame: 24 hours
Population: Only 98 participants of the total of 179 responded the survey to assess the convenience of use of the Holter systems
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holter Device | Holter System Convenience of Use | Innovative 3-lead Wireless Water Resistant Holter System | 54 Participants |
| Holter Device | Holter System Convenience of Use | Conventional Holter System | 14 Participants |
| Holter Device | Holter System Convenience of Use | No difference | 30 Participants |
p-value: <0.0001Chi-squared
Secondary
Maximum Heart Rate
Maximum heart rate measured in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Maximum Heart Rate | Innovative 3-lead Wireless Water Resistant Holter System | 113.59 beats per minute | Standard Deviation 23.17 |
| Holter Device | Maximum Heart Rate | Conventional Holter System | 116.30 beats per minute | Standard Deviation 24.76 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-17.09, 11.67]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.93, 0.96]
Secondary
Mean Heart Rate
Mean heart rate measured in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Mean Heart Rate | Innovative 3-lead Wireless Water Resistant Holter System | 69.73 beats per minute | Standard Deviation 12.1 |
| Holter Device | Mean Heart Rate | Conventional Holter System | 70.67 beats per minute | Standard Deviation 12.24 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-6.2, 4.31]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.96, 0.98]
Secondary
Minimum Heart Rate
Minimum heart rate measured in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Minimum Heart Rate | Innovative 3-lead Wireless Water Resistant Holter System | 49.56 beats per minute | Standard Deviation 9.83 |
| Holter Device | Minimum Heart Rate | Conventional Holter System | 49.17 beats per minute | Standard Deviation 8.87 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-5.43, 6.22]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.93, 0.96]
Secondary
Ventricular Ectopic Heart Beats
Total number of ventricular ectopic heart beats measured in both Holter monitors
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Holter Device | Ventricular Ectopic Heart Beats | Innovative 3-lead Wireless Water Resistant Holter System | 1198.89 ventricular ectopic heart beats in 24 hr | Standard Deviation 2651.33 |
| Holter Device | Ventricular Ectopic Heart Beats | Conventional Holter System | 1187.85 ventricular ectopic heart beats in 24 hr | Standard Deviation 2696.69 |
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [-2089.58, 2111.65]
Comparison: The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).95% CI: [0.89, 0.94]