Telemetric Arrhythmia Diagnosis in Adults

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

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-03-31

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 in comparison with a standard Holter ECG recording and an Event Holter recording to diagnose cardiac arrhythmia.

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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 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 increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring and 14 days telemetric full disclosure ECG monitoring. The full disclosure signal will be subsequently analyzed in the Event Monitoring mode by an independent consultant. Efficacy of Telemetric Monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Monitoring.

Conditions

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Atrial Fibrillation Arrhythmia

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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Telemetric ECG monitoring

Telemetric 14-days Full Disclosure ECG recording.

Group Type EXPERIMENTAL

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Standard 24-hours Holter ECG recording

Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.

Group Type ACTIVE_COMPARATOR

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Interventions

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Prolonged telemetric Full Disclosure ECG recording.

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Intervention Type DEVICE

Other Intervention Names

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Medicalgorithmics, PocketECG

Eligibility Criteria

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Inclusion Criteria

* Age - between 18 and 80 years old
* History of symptoms potentially caused by arrhythmia
* Symptoms occuring at least monthly
* Patient informed consent
* Declarative and feasible compliance (patient understands basic instructions regarding device use)