Telemetric Arrhythmia Diagnosis in Adults

Study Overview
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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.

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.

Official Title
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OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults

Conditions
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Atrial Fibrillation, Arrhythmia

Intervention / Treatment
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* Device: Prolonged telemetric Full Disclosure ECG recording.


Participation Criteria
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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) Exclusion Criteria: Evidence of previously recorded arrhythmia Inability to comply with the study protocol Lack of patient cooperation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemetric ECG monitoring<br>Telemetric 14-days Full Disclosure ECG recording. | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days<br>* Other names: Medicalgorithmics, PocketECG;|
| Active Comparator: Standard 24-hours Holter ECG recording<br>Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier. | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days<br>* Other names: Medicalgorithmics, PocketECG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of symptomatic or life threatening arrhythmia event | ECG monitoring is conducted until occurrence of symptomatic arrhythmia or life threatening arrhythmia but not longer than 14 days. Patients in the control group will have standard ECG Holter monitoring repeated 3 times unless arrhythmia is diagnosed earlier. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence. | 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. | 14 days | 
| Silent (asymptomatic) arrhythmia events incidence detection assessment | Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications Atrial fibrillation Atrial flutter Atrial Tachycardia Ventricular tachycardia | 14 days | 
| Evaluation of stroke and bleeding risk factors incidence | Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Cardiac arrhythmia, ECG, Telemonitoring, Telemetry, Holter