N/A
Completed N=231
A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System
Cardiac Arrhythmia
Source: ClinicalTrials.gov NCT04723355 ↗
Enrolled (actual)
231
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Detection of Cardiac Arrhythmias — 107; 104 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Cardiac Arrhythmias |
107; 104 | — |
| SECONDARY Detection of Atrial Fibrillation or Atrial Flutter |
23; 22 | — |
| SECONDARY Detection of Supraventricular Tachycardia |
71; 71 | — |
| SECONDARY Detection of Ventricular Tachycardia |
26; 23 | — |
| SECONDARY Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation |
14; 12 | — |
| SECONDARY Detection of Atrioventricular Block |
5; 4 | — |
| SECONDARY Detection of Heart Beat Pauses |
7; 11 | — |
| SECONDARY Duration of the Holter Exam |
21.79; 21.74 | — |
| SECONDARY Mean Heart Rate |
69.73; 70.67 | — |
| SECONDARY Maximum Heart Rate |
113.59; 116.30 | — |
| SECONDARY Minimum Heart Rate |
49.56; 49.17 | — |
| SECONDARY Atrial Ectopic Heart Beats |
717.09; 723.46 | — |
| SECONDARY Ventricular Ectopic Heart Beats |
1198.89; 1187.85 | — |
| SECONDARY Episodes of Ventricular Tachycardia |
1.12; 1.24 | — |
| SECONDARY Episodes of Supraventricular Tachycardia |
5.71; 6.37 | — |
| SECONDARY Episodes of Heart Beat Pauses |
1.74; 1.84 | — |
| SECONDARY Holter System Convenience of Use |
54; 14; 30 | <0.0001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04723355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.