Arrhythmia, Children
Conditions
Keywords
Arrhythmia, Children
Brief summary
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
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
Interventions
Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode
Repeated 24 hours ECG Holter monitoring
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recording of symptomatic or life threatening arrhythmia event | within 30 days since the start of monitoring | 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 |
Secondary
| Measure | 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 |
Countries
Poland
Contacts
Primary ContactKatarzyna Bieganowska, Prof. MD PhD
Backup ContactMaria Miszczak-Knecht, MD PhD
Outcome results
None listed