Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions

Not Applicable

• Conditions: Arrhythmia; Children
• Interventions: Device: Prolonged telemetric Full Disclosure ECG recording.; Device: Repeated 24 hours ECG Holter monitoring

• Registration Number: NCT01265771
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Study Start: 2011-02
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-02
• Last Update Posted: 2011-12-05
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemetry ordered by a Cardiologist	Prolonged telemetric Full Disclosure ECG recording.	-
24 hours standard Holter monitoring	Repeated 24 hours ECG Holter monitoring	-
Telemetry ordered by a Pediatrician	Prolonged telemetric Full Disclosure ECG recording.	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Institute of Cardiology; 🇵🇱 Warsaw, Poland

Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics; 🇵🇱 Warsaw, Poland

The Children's Memmorial Health Institute; 🇵🇱 Warsaw, Poland