Validation of a mobile bedside ECG Screening Tool for Arrhythmias in primary care practice

Completed

• Conditions: atrial fibrillation; 10007521

• Registration Number: NL-OMON47469
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-07-22
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 214

Inclusion Criteria

Patients who are scheduled for a standard 12-lead electrocardiogram in a primary care setting

Exclusion Criteria

Patients suspected of acute coronary syndrome, hemodynamically unstable, permanent pacemaker and/or ICD, unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Specificity and sensitivity of Livv Mobiel ECG versus standard 12-lead ECG in<br /><br>detecting cardiac arrhythmias</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Agreement of the built-in software algorithm and cardiologist overread for<br /><br>atrial fibrillation<br /><br>2) Nurse and/or primary care physician satisfaction regarding device utility<br /><br><br /><br>A sensitivity analysis will be performed in patients with symptoms (symptom<br /><br>driven ECG) and in those in whom an ECG is performed as part of routine<br /><br>CVRM/diabetes care (protocol-driven ECG).</p><br>