Optimizing Diagnostics Of Syncope Events 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 syncope in comparison with standard diagnostic procedure

Detailed Description
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Syncope can be caused by many conditions, often benign but in some cases syncope can be a symptom of severe arrhythmia. Early diagnosis of the underlying disease is very important to identify patients with severe cardiac arrhythmia to commence adequate treatment. 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 adequate 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 Syncope In Children.

Conditions
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Cardiac Arrhythmia, Cardiogenic Syncope

Intervention / Treatment
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* Device: repeated 24 hours ECG Holter monitoring
* Device: Telemetric ECG monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of syncope Ability to operate the telemetric device at home Exclusion of underlying neurological disease informed consent undersigned by the parents informed consent undersigned by the child if over 16 years of age Exclusion Criteria: Syncope with known underlying disease Inability to operate the telemetric device at home Complete Heart block QT>500ms Implantation of ICD 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: Telemetric ECG monitoring<br>Telemetric Full Disclosure ECG monitoring | Device: Telemetric ECG monitoring<br>* Telemetric ECG full disclosure monitoring with GSM technology<br>|
| Experimental: 24 hours standard Holter monitoring<br> | Device: repeated 24 hours ECG Holter monitoring<br>* repeated 24 hours ECG Holter monitoring<br>|

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 | 
| 1. Verification of patient self assessment based on the Quality of Life questionnaire and 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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Cardiac arrhythmia, Cardiogenic syncope, Pediatrics, Children