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Clinical Trials/NCT01265758
NCT01265758
Unknown
Not Applicable

OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults

National Institute of Cardiology, Warsaw, Poland2 sites in 1 country360 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
National Institute of Cardiology, Warsaw, Poland
Enrollment
360
Locations
2
Primary Endpoint
Recording of symptomatic or life threatening arrhythmia event
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
March 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Cardiology, Warsaw, Poland

Eligibility Criteria

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

Outcomes

Primary Outcomes

Recording of symptomatic or life threatening arrhythmia event

Time Frame: 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 Outcomes

  • Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.(14 days)
  • Silent (asymptomatic) arrhythmia events incidence detection assessment(14 days)
  • Evaluation of stroke and bleeding risk factors incidence(14 days)

Study Sites (2)

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