Telemetric Arrhythmia Diagnosis in Adults (TELEMARC1)

National Institute of Cardiology, Warsaw, Poland

Status: Unknown

Conditions: Arrhythmia; Atrial Fibrillation

Treatments: Device: Prolonged telemetric Full Disclosure ECG recording.

Study type: Interventional

Funder types: Other

Identifiers

NCT01265758

UDAPOIG.01.03.01-00-068/09-00A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Telemetric ECG monitoring

Experimental group

Description:

Telemetric 14-days Full Disclosure ECG recording.

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.

Standard 24-hours Holter ECG recording

Active Comparator group

Description:

Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.