Arrhythmia, Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Cardiac arrhythmia, ECG, Telemonitoring, Telemetry, Holter
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.
Interventions
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Contacts
Primary ContactLukasz Szumowski, MD, PhD
Backup ContactZbigniew Jedynak, MD, PhD
Outcome results
None listed