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| Sponsor: | Institute of Cardiology, Warsaw, Poland |
|---|---|
| Information provided by: | Institute of Cardiology, Warsaw, Poland |
| ClinicalTrials.gov Identifier: | NCT01265758 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Arrhythmia |
Device: Prolonged telemetric Full Disclosure ECG recording. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults |
Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications
| Estimated Enrollment: | 360 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Telemetric ECG monitoring
Telemetric 14-days Full Disclosure ECG recording.
|
Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG
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Active Comparator: Standard 24-hours Holter ECG recording
Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.
|
Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lukasz Szumowski, MD, PhD | +48501152728 | lszumowski@ikard.pl |
| Contact: Zbigniew Jedynak, MD, PhD | +48603786780 | zjedynak@ikard.pl |
| Poland | |
| The Medical University of Gdańsk | Recruiting |
| Gdansk, Poland, 80-210 | |
| Contact: Janusz Siebert, Prof. MD PhD jsiebert@amg.gda.pl | |
| Principal Investigator: Janusz Siebert, Prof. MD PhD | |
| Institute of Cardiology | Recruiting |
| Warsaw, Poland, 04-628 | |
| Contact: Lukasz Szumowski, Prof, +48 22 501152728 lszumowski@ikard.pl | |
| Principal Investigator: Lukasz Szumowski, Prof. MD PhD | |
| Study Chair: | Lukasz J Szumowski, MD, PhD | Institute of Cardiology, Warsaw, Poland |
More Information
| Responsible Party: | Prof Lukasz Szumowski, Institute of Cardiology, Warsaw Poland |
| ClinicalTrials.gov Identifier: | NCT01265758 History of Changes |
| Other Study ID Numbers: | UDAPOIG.01.03.01-00-068/09-00A |
| Study First Received: | December 21, 2010 |
| Last Updated: | December 2, 2011 |
| Health Authority: | Poland: Ethics Committee |
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Atrial fibrillation Cardiac arrhythmia ECG |
Telemonitoring Telemetry Holter |
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Arrhythmias, Cardiac Atrial Fibrillation Heart Diseases Cardiovascular Diseases Pathologic Processes |