Brief Summary

Skip to Participation Criteria

Official Title: "Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Study Primary Completion Date: December 2012

Detailed Clinical Trial 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

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Telemetry ordered by a Cardiologist
• Experimental: 24 hours standard Holter monitoring
• Experimental: Telemetry ordered by a Pediatrician

Outcome Measures for this Clinical Trial

Primary Measures

• Recording of symptomatic or life threatening arrhythmia event
  • Time Frame: within 30 days since the start of monitoring
    Safety Issue?: No

Secondary Measures

• Occurrence of silent (asymptomatic) arrhythmia event
  • Time Frame: within 30 days since the start of monitoring
    Safety Issue?: No
• 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
  • Time Frame: within 30 days since the start of monitoring
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Institute of Cardiology, Warsaw, Poland
• Provider of Information About this Clinical Study
  • Prof. Lukasz Szumowski MD PhD, Institute of Cardiology, Warsaw
• Overall Official(s)
  • Lukasz Szumowski, Prof. MD PhD, Study Chair, Institute of Cardiology, Warsaw, Poland
  • Katarzyna Bieganowska, Prof. MD PhD, Principal Investigator, Children's Memorial Health Institute
• Overall Contact(s)
  • Katarzyna Bieganowska, Prof. MD PhD, kbieganowska@wp.pl