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Arrhythmia | Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions

Arrhythmia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arrhythmia

Children

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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 monitoringRepeated 24 hours ECG Holter monitoring

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Telemetry ordered by a Cardiologist

24 hours standard Holter monitoring

Telemetry ordered by a Pediatrician

Study Status

Unknown status

Start Date: February 2011

Completed Date: January 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Recording of symptomatic or life threatening arrhythmia event

Secondary Outcome: Occurrence of silent (asymptomatic) arrhythmia event

Study sponsors, principal investigator, and references

Principal Investigator: Lukasz Szumowski, Prof. MD PhD

Lead Sponsor: Institute of Cardiology, Warsaw, Poland

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01265771

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