Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Blackpool Teaching Hospitals NHS Foundation Trust
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of alivecor recording
- Last Updated
- 5 years ago
Overview
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.
Investigators
Dr. Khalid Abozguia
Consultant Cardiologist and Electrophysiologist
Blackpool Teaching Hospitals NHS Foundation Trust
Eligibility Criteria
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
Outcomes
Primary Outcomes
Diagnostic accuracy of alivecor recording
Time Frame: 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.