NCT03996954

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Blackpool Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
DEVICE	Alivecor recording	Alivecor recording and ECG recording from the same patient in very close temporal proximity

Timeline

• Start date: 2018-10-08
• Primary completion: 2020-10-07
• Completion: 2020-10-07
• First posted: 2019-06-25
• Last updated: 2020-09-16

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study