Status:
UNKNOWN
Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Conditions:
Cardiac Arrhythmia
Cardiogenic Syncope
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 to diagnose syncope in comparis...
Detailed Description
Syncope can be caused by many conditions, often benign but in some cases syncope can be a symptom of severe arrhythmia. Early diagnosis of the underlying disease is very important to identify patients...
Eligibility Criteria
Inclusion
- History of syncope
- Ability to operate the telemetric device at home
- Exclusion of underlying neurological disease
- informed consent undersigned by the parents
- informed consent undersigned by the child if over 16 years of age
Exclusion
- Syncope with known underlying disease
- Inability to operate the telemetric device at home
- Complete Heart block
- QT\>500ms
- Implantation of ICD
- Inability to comply with the study protocol
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT01265290
Start Date
February 1 2011
End Date
January 1 2013
Last Update
December 5 2011
Active Locations (2)
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1
Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics
Warsaw, Poland, 00-576
2
The Children's Memmorial Health Institute
Warsaw, Poland, 04-730