Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions

Children Clinical Trial

— TELEMARC2  

Official title:

Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265771
• Other study ID #: UDAPOIG.01.03.01-00-068/09-00B
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2010
• Last updated: December 2, 2011
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2011
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Katarzyna Bieganowska, Prof. MD PhD
• Email: kbieganowska[@]wp.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmia
• Children

Intervention

Device:
• Prolonged telemetric Full Disclosure ECG recording.
Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode
• Repeated 24 hours ECG Holter monitoring
Repeated 24 hours ECG Holter monitoring

Locations

Country	Name	City	State
Poland	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

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of symptomatic or life threatening arrhythmia event	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	within 30 days since the start of monitoring	No
Secondary	Occurrence of silent (asymptomatic) arrhythmia event		within 30 days since the start of monitoring	No
Secondary	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	No