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Telemetric Arrhythmia Diagnosis in Adults (TELEMARC1)

This study is currently recruiting participants.
Verified February 2013 by Institute of Cardiology, Warsaw, Poland
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01265758
First received: December 21, 2010
Last updated: February 18, 2013
Last verified: February 2013
History of Changes

December 21, 2010
February 18, 2013
February 2011
March 2014   (final data collection date for primary outcome measure)
Recording of symptomatic or life threatening arrhythmia event [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01265758 on ClinicalTrials.gov Archive Site
  • Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Verification of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale against evidence of cardiac arrhythmia occurrence.
  • Silent (asymptomatic) arrhythmia events incidence detection assessment [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications

    1. Atrial fibrillation
    2. Atrial flutter
    3. Atrial Tachycardia
    4. Ventricular tachycardia
  • Evaluation of stroke and bleeding risk factors incidence [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED.
Same as current
Not Provided
Not Provided
 
Telemetric Arrhythmia Diagnosis in Adults
OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Atrial Fibrillation
  • Arrhythmia
Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG
  • Experimental: Telemetric ECG monitoring
    Telemetric 14-days Full Disclosure ECG recording.
    Intervention: Device: Prolonged telemetric Full Disclosure ECG recording.
  • Active Comparator: Standard 24-hours Holter ECG recording
    Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.
    Intervention: Device: Prolonged telemetric Full Disclosure ECG recording.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Lukasz Szumowski, MD, PhD +48501152728 lszumowski@ikard.pl
Contact: Zbigniew Jedynak, MD, PhD +48603786780 zjedynak@ikard.pl
Poland
 
NCT01265758
UDAPOIG.01.03.01-00-068/09-00A
No
Prof Lukasz Szumowski, Institute of Cardiology, Warsaw Poland
Institute of Cardiology, Warsaw, Poland
Not Provided
Study Chair: Lukasz J Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP