Clinical trial NCT01265758: Telemetric Arrhythmia Diagnosis in Adults
Official title: OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmia
Keywords: Atrial fibrillation
Cardiac arrhythmia
ECG
Telemonitoring
Telemetry
Holter
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Recording of symptomatic or life threatening arrhythmia event
timeFrame: 14 days
Secondary outcomes:
measure: Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.
timeFrame: 14 days
measure: Silent (asymptomatic) arrhythmia events incidence detection assessment
timeFrame: 14 days
measure: Evaluation of stroke and bleeding risk factors incidence
timeFrame: 14 days
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: The Medical University of Gdańsk
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz J Szumowski, MD, PhD
role: STUDY_CHAIR
References: