18 and older, any sex, with Cardiac Arrhythmia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Detection of Cardiac ArrhythmiasPrimary· 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 f
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
107
Conventional Holter System
Group
Value
95% CI
Holter Device
104
Detection of Atrial Fibrillation or Atrial FlutterSecondary· 24 hours
Number of patients with atrial fibrillation or atrial flutter detected in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
23
Conventional Holter System
Group
Value
95% CI
Holter Device
22
Detection of Supraventricular TachycardiaSecondary· 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
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
71
Conventional Holter System
Group
Value
95% CI
Holter Device
71
Detection of Ventricular TachycardiaSecondary· 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
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
26
Conventional Holter System
Group
Value
95% CI
Holter Device
23
Detection of Polymorphic Ventricular Tachycardia or Ventricular FibrillationSecondary· 24 hours
Number of patients with polymorphic ventricular tachycardia or ventricular fibrillation detected in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
14
Conventional Holter System
Group
Value
95% CI
Holter Device
12
Detection of Atrioventricular BlockSecondary· 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
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
5
Conventional Holter System
Group
Value
95% CI
Holter Device
4
Detection of Heart Beat PausesSecondary· 24 hours
Number of patients with heart beat pauses ≥ 2.5 seconds detected in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
7
Conventional Holter System
Group
Value
95% CI
Holter Device
11
Duration of the Holter ExamSecondary· 24 hours
Duration of the Holter exam in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
21.79
± 1.40
Conventional Holter System
Group
Value
95% CI
Holter Device
21.74
± 1.95
Mean Heart RateSecondary· 24 hours
Mean heart rate measured in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
69.73
± 12.10
Conventional Holter System
Group
Value
95% CI
Holter Device
70.67
± 12.24
Maximum Heart RateSecondary· 24 hours
Maximum heart rate measured in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
113.59
± 23.17
Conventional Holter System
Group
Value
95% CI
Holter Device
116.30
± 24.76
Minimum Heart RateSecondary· 24 hours
Minimum heart rate measured in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
49.56
± 9.83
Conventional Holter System
Group
Value
95% CI
Holter Device
49.17
± 8.87
Atrial Ectopic Heart BeatsSecondary· 24 hours
Total number of atrial ectopic heart beats measured in both Holter monitors
Innovative 3-lead Wireless Water Resistant Holter System
Group
Value
95% CI
Holter Device
717.09
± 2323.94
Conventional Holter System
Group
Value
95% CI
Holter Device
723.46
± 2223.27
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospital Israelita Albert Einstein
Last refreshed: 24 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04723355.