Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Syncope In Children.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Enrollment
- 640
- Locations
- 2
- Primary Endpoint
- Recording of symptomatic or life threatening arrhythmia event
- Last Updated
- 14 years ago
Overview
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 syncope in comparison with standard diagnostic procedure
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Recording of symptomatic or life threatening arrhythmia event
Time Frame: 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 Outcomes
- 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)