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

Not Applicable

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT03996954
• Lead Sponsor: Blackpool Teaching Hospitals NHS Foundation Trust

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-10-08
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-22
• Study First Posted: 2019-06-25
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of alivecor recording	Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.	For each patient two diagnoses of their underlying heart rhythm will be provided by blinded reporters. The percentage match of these diagnoses (the ratio of identical diagnoses to mismatch in diagnoses between ECG report and Alivecor report will be used as a measure of accuracy of the Alivecor to differentiate between different heart rhythms, using the 12 lead ECG as the gold standard for cardiac rhythm diagnosis.

Trial Locations

Locations (1)

Blackpool Teaching Hospitals NHS Foundation Trust; 🇬🇧 Blackpool, Lancashire, United Kingdom