| 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) | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| Innovative 3-lead Wireless Water Resistant Holter System | | | | Conventional Holter System | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | | | | | Accuracy | 0.87 | | | 2-Sided | 95 | 0.81 | 0.92 | | | | | Non-Inferiority | In the sample size calculations, we assumed that the innovative 3-lead wireless water resistant Holter System would have a concordance in the diagnosis of arrhythmia compared to the conventional Holter device similar to a previous study that compared a patch to the conventional Holter device. With this assumption, a total sample of 182 participants would have 80% power to demonstrate an accuracy of at least 85% with a significance level of 2.5% (the 95% CI lower limit should be above 85%). |
|
| Secondary | Detection of Atrial Fibrillation or Atrial Flutter | Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation | Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Detection of Heart Beat Pauses | Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors | | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Duration of the Holter Exam | Duration of the Holter exam in both Holter monitors | | Posted | | Mean | Standard Deviation | hours | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Mean Heart Rate | Mean heart rate measured in both Holter monitors | | Posted | | Mean | Standard Deviation | beats per minute | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Maximum Heart Rate | Maximum heart rate measured in both Holter monitors | | Posted | | Mean | Standard Deviation | beats per minute | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Minimum Heart Rate | Minimum heart rate measured in both Holter monitors | | Posted | | Mean | Standard Deviation | beats per minute | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Atrial Ectopic Heart Beats | Total number of atrial ectopic heart beats measured in both Holter monitors | | Posted | | Mean | Standard Deviation | atrial ectopic heart beats in 24 hr | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Ventricular Ectopic Heart Beats | Total number of ventricular ectopic heart beats measured in both Holter monitors | | Posted | | Mean | Standard Deviation | ventricular ectopic heart beats in 24 hr | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Episodes of Ventricular Tachycardia | Total number of ventricular tachycardia episodes detected in both Holter monitors | | Posted | | Mean | Standard Deviation | ventricular tachycardia episodes in 24hr | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Episodes of Supraventricular Tachycardia | Total number of supraventricular tachycardia episodes detected in both Holter monitors | | Posted | | Mean | Standard Deviation | supraventricular tachycardia episodes | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Episodes of Heart Beat Pauses | Total number of heart beat pauses ≥ 2.5 seconds detected in both Holter monitors | | Posted | | Mean | Standard Deviation | heart beat pauses in 24hr | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Holter System Convenience of Use | Number of Participants Reporting the convenience of use of the Holter systems | Only 98 participants of the total of 179 responded the survey to assess the convenience of use of the Holter systems | Posted | | Count of Participants | | Participants | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |