Telemetric Arrhythmia Diagnosis in Adults
TELEMARC1
OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults
1 other identifier
interventional
360
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Feb 2011
Typical duration for not_applicable atrial-fibrillation
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFebruary 20, 2013
February 1, 2013
3.1 years
December 21, 2010
February 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recording of symptomatic or life threatening arrhythmia event
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.
14 days
Secondary Outcomes (3)
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 Arms (2)
Telemetric ECG monitoring
EXPERIMENTALTelemetric 14-days Full Disclosure ECG recording.
Standard 24-hours Holter ECG recording
ACTIVE COMPARATORStandard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.
Interventions
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Evidence of previously recorded arrhythmia
- Inability to comply with the study protocol
- Lack of patient cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Medical University of Gdańsk
Gdansk, 80-210, Poland
Institute of Cardiology
Warsaw, 04-628, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lukasz J Szumowski, MD, PhD
National Institute of Cardiology, Warsaw, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2010
First Posted
December 23, 2010
Study Start
February 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
February 20, 2013
Record last verified: 2013-02