Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions. (TELEMARC3)

National Institute of Cardiology, Warsaw, Poland

Status: Unknown

Conditions: Cardiogenic Syncope; Cardiac Arrhythmia

Treatments: Device: repeated 24 hours ECG Holter monitoring; Device: Telemetric ECG monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01265290

UDAPOIG.01.03.01-00-068/09-00C

Details and patient eligibility

About

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

Full 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.

Enrollment: 640 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

Telemetric ECG monitoring

Experimental group

Description:

Telemetric Full Disclosure ECG monitoring

Treatment:

Device: Telemetric ECG monitoring

24 hours standard Holter monitoring

Experimental group

Treatment:

Device: repeated 24 hours ECG Holter monitoring