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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47469

Enrollment

250

Registered

2017-04-04

Start date

2017-04-04

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

A 30-second single-lead ECG registration by holding a small metal device that is connected to a secure smartphone ("Livv Mobiel ECG", Livv Mobile Health B.V., Zwolle, Netherlands). The investigation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Specificity and sensitivity of Livv Mobiel ECG versus standard 12-lead ECG in detecting cardiac arrhythmias	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)