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Cardiac Arrhythmia | Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

Cardiac 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 syncope in comparison with standard diagnostic procedure

Who is eligible to participate?

Inclusion Criteria: - History of syncope - Ability to operate the telemetric device at home - Exclusion of underlying neurological disease - informed consent undersigned by the parents - informed consent undersigned by the child if over 16 years of age Exclusion Criteria: - Syncope with known underlying disease - Inability to operate the telemetric device at home - Complete Heart block - QT>500ms - Implantation of ICD - Inability to comply with the study protocol

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

Cardiac Arrhythmia

Cardiogenic Syncope

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:repeated 24 hours ECG Holter monitoringrepeated 24 hours ECG Holter monitoring

Device:Telemetric ECG monitoringTelemetric ECG full disclosure monitoring with GSM technology

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.

Telemetric ECG monitoringTelemetric Full Disclosure ECG monitoring

24 hours standard Holter monitoring

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/NCT01265290

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