Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias

NHS Foundation Trust

Status: Unknown

Conditions: Cardiac Arrhythmia

Treatments: Device: Alivecor recording

Study type: Interventional

Funder types: Other

Identifiers

NCT03996954

IRAS Project ID:245687

Details and patient eligibility

About

The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia

Full description

The investigators are planning to record 250 pre-defined abnormal ECGs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, , supraventricular tachycardia) and 150 control ECGs (100 sinus rhythm, 50 sinus tachycardia) using both the AliveCor Smartphone device and a 12-lead ECG. All 400 ECGs will then be read by 3 blinded reporters - a Consultant Electrophysiologist, a Consultant General Cardiologist and a General Practitioner. The output of the AliveCor automatic detection algorithm will also be recorded as a fourth reporter. The screening characteristics of all 4 reporters using the AliveCor device vs the definitive 12 lead ECG will be analysed and compared.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female patients >18 years
• 12 lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia

Exclusion criteria

• Age <18 years
• Patients unable to or unwilling to use the device
• Patients with cardiac pacemaker, ICDs, or other implanted electronic devices

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Normal ECGs

Active Comparator group

Description:

Patients with normal ECGs

Treatment:

Device: Alivecor recording

Abnormal ECGs

Active Comparator group

Description:

Patients with different kinds of abnormal heart rhythms will be enrolled in order to compare whether Alivecor can accurately differentiate between these abnormal heart rhythms and normal sinus rhythm/sinus tachycardia. Also, Alivecor diagnostic accuracy in differentiating between different kinds of arrhythmias will be assessed.

Treatment:

Device: Alivecor recording