Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions

Study Overview
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Brief Summary
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The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology to diagnose arrhythmia in comparison with standard diagnostic procedure.

Detailed Description
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Irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. Together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). In others, palpitations result from heart rhythm disturbances, sometimes life threatening. Standard diagnostic methods such as 24 hours Holter electrocardiogram (ECG) monitoring or Event Holter do not guarantee early diagnosis of the arrhythmia. Prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device can increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring, Event Holter or 30 days telemetric ECG monitoring. Efficacy of telemetric monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Holter

Official Title
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Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children

Conditions
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Arrhythmia, Children

Intervention / Treatment
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* Device: Prolonged telemetric Full Disclosure ECG recording.
* Device: Repeated 24 hours ECG Holter monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of symptoms that can be potentially caused by cardiac arrhythmia occuring at least 4 times a year Ability to operate the telemetric device at home Informed consent undersigned by the parents Informed consent undersigned by the child if over 16 years of age Exclusion Criteria: Previously recorded tachycardia evidence Wolff Parkinson White syndrome Inability to operate the telemetric device at home Inability to comply with the study protocol

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemetry ordered by a Cardiologist<br> | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode<br>* Other names: Pocket ECG, Medicalgorithmics;|
| Experimental: 24 hours standard Holter monitoring<br> | Device: Repeated 24 hours ECG Holter monitoring<br>* Repeated 24 hours ECG Holter monitoring<br>|
| Experimental: Telemetry ordered by a Pediatrician<br> | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode<br>* Other names: Pocket ECG, Medicalgorithmics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of symptomatic or life threatening arrhythmia event | ECG monitoring is conducted until occurrence of symptomatic arrhythmia or life threatening arrhythmia but not longer than 30 days. Patients in the control group will have standard ECG Holter monitoring repeated twice | within 30 days since the start of monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of silent (asymptomatic) arrhythmia event |  | within 30 days since the start of monitoring | 
| Verification of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale against evidence of cardiac arrhythmia occurrence |  | within 30 days since the start of monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrhythmia, Children