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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemetry ordered by a Cardiologist | Experimental |
| |
| 24 hours standard Holter monitoring | Experimental |
| |
| Telemetry ordered by a Pediatrician | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged telemetric Full Disclosure ECG recording. | Device | Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode |
|
| 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 30 days. Patients in the control group will have standard ECG Holter monitoring repeated twice | within 30 days since the start of monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of silent (asymptomatic) arrhythmia event | within 30 days since the start of monitoring | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Bieganowska, Prof. MD PhD | Contact | kbieganowska@wp.pl | ||
| Maria Miszczak-Knecht, MD PhD | Contact | mmknecht@neostrada.pl |
| Name | Affiliation | Role |
|---|---|---|
| Lukasz Szumowski, Prof. MD PhD | National Institute of Cardiology, Warsaw, Poland | Study Chair |
| Katarzyna Bieganowska, Prof. MD PhD | Children's Memorial Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics | Recruiting | Warsaw | 00-576 | Poland |
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|
| Repeated 24 hours ECG Holter monitoring | Device | Repeated 24 hours ECG Holter monitoring |
|
| within 30 days since the start of monitoring |
| Institute of Cardiology | Recruiting | Warsaw | 04-620 | Poland |
|
| The Children's Memmorial Health Institute | Recruiting | Warsaw | 04-730 | Poland |
|
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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