Atrial Fibrillation | Telemetric Arrhythmia Diagnosis in Adults
Atrial Fibrillation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Prolonged telemetric Full Disclosure ECG recording.Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Telemetric ECG monitoringTelemetric 14-days Full Disclosure ECG recording.
Standard 24-hours Holter ECG recordingStandard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.
Start Date: February 2011
Completed Date: March 2014
Primary Outcome: Recording of symptomatic or life threatening arrhythmia event
Secondary Outcome: Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.
Study sponsors, principal investigator, and references
Principal Investigator: Lukasz J Szumowski, MD, PhD
Lead Sponsor: Institute of Cardiology, Warsaw, Poland