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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996954
• Other study ID #: IRAS Project ID:245687
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: October 7, 2020

Study information

• Verified date: September 2020
• Source: Blackpool Teaching Hospitals NHS Foundation Trust
• Contact: Khalid Abozguia, Ph.D.
• Phone: 00441253957780
• Email: k.abozguia[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• Alivecor recording
Alivecor recording and ECG recording from the same patient in very close temporal proximity

Locations

Country	Name	City	State
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust	Blackpool	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Blackpool Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of alivecor recording	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.	Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.