Telemetric Arrhythmia Diagnosis in Adults

Not Applicable

• Conditions: Atrial Fibrillation; Arrhythmia

• Registration Number: NCT01265758
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Study Start: 2011-02
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-18
• Last Update Posted: 2013-02-20
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recording of symptomatic or life threatening arrhythmia event	14 days	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.	14 days	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.
Silent (asymptomatic) arrhythmia events incidence detection assessment	14 days	Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications; 1. Atrial fibrillation; 2. Atrial flutter; 3. Atrial Tachycardia; 4. Ventricular tachycardia
Evaluation of stroke and bleeding risk factors incidence	14 days	Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED.

Trial Locations

Locations (2)

The Medical University of Gdańsk; 🇵🇱 Gdansk, Poland

Institute of Cardiology; 🇵🇱 Warsaw, Poland