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Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions

NCT ID: NCT01265771

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-01-31

Brief Summary

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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

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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

Conditions

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Arrhythmia Children

Keywords

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Arrhythmia Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Telemetry ordered by a Cardiologist

Group Type EXPERIMENTAL

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode

24 hours standard Holter monitoring

Group Type EXPERIMENTAL

Repeated 24 hours ECG Holter monitoring

Intervention Type DEVICE

Repeated 24 hours ECG Holter monitoring

Telemetry ordered by a Pediatrician

Group Type EXPERIMENTAL

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode

Interventions

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Prolonged telemetric Full Disclosure ECG recording.

Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode

Intervention Type DEVICE

Repeated 24 hours ECG Holter monitoring

Repeated 24 hours ECG Holter monitoring

Intervention Type DEVICE

Other Intervention Names

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Pocket ECG, Medicalgorithmics

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cardiology, Warsaw

Principal Investigators

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Lukasz Szumowski, Prof. MD PhD

Role: STUDY_CHAIR

National Institute of Cardiology, Warsaw, Poland

Katarzyna Bieganowska, Prof. MD PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Memorial Health Institute

Locations

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Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics

Warsaw, , Poland

Site Status RECRUITING

Institute of Cardiology

Warsaw, , Poland

Site Status RECRUITING

The Children's Memmorial Health Institute

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Katarzyna Bieganowska, Prof. MD PhD

Role: CONTACT

Email: [email protected]

Maria Miszczak-Knecht, MD PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bożena Werner, MD PhD

Role: primary

Lukasz Szumowski, Prof

Role: primary

Katarzyna Bieganowska, Prof. MD PhD

Role: primary

Maria Miszczak-Knecht, MD PhD

Role: backup

Other Identifiers

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UDAPOIG.01.03.01-00-068/09-00B

Identifier Type: -

Identifier Source: org_study_id