Telemetric Arrhythmia Diagnosis in Adults

Atrial Fibrillation Clinical Trial

— TELEMARC1  

Official title:

OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265758
• Other study ID #: UDAPOIG.01.03.01-00-068/09-00A
• Status: Recruiting
• Phase: N/A
• First received: December 21, 2010
• Last updated: February 18, 2013
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: February 2013
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Lukasz Szumowski, MD, PhD
• Phone: +48501152728
• Email: lszumowski[@]ikard.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Device:
• Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Locations

Country	Name	City	State
Poland	The Medical University of Gdansk	Gdansk
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.	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.	14 days	No
Secondary	Silent (asymptomatic) arrhythmia events incidence detection assessment	Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications; Atrial fibrillation; Atrial flutter; Atrial Tachycardia; Ventricular tachycardia	14 days	No
Secondary	Evaluation of stroke and bleeding risk factors incidence	Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED.	14 days	No