Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions (TELEMARC2)

National Institute of Cardiology, Warsaw, Poland

Status: Unknown

Conditions: Arrhythmia; Children

Treatments: Device: Prolonged telemetric Full Disclosure ECG recording.; Device: Repeated 24 hours ECG Holter monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01265771

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

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 arrhythmia in comparison with standard diagnostic procedure.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

Telemetry ordered by a Cardiologist

Experimental group

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.

24 hours standard Holter monitoring

Experimental group

Treatment:

Device: Repeated 24 hours ECG Holter monitoring

Telemetry ordered by a Pediatrician

Experimental group

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.