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

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

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Alivecor recording

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khalid Abozguia, Ph.D.; Phone Number: 00441253957780; Email: k.abozguia@nhs.net
• Study Contact Backup: Name: Dimitrios Katsaras, MD; Phone Number: 00441253957780; Email: d.katsaras@nhs.net

Study Locations

• United Kingdom
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY3 8NR
      • Recruiting
      • Blackpool Teaching Hospitals NHS Foundation Trust
      • Contact: Dimitrios Katsaras, MD; Phone Number: 00441253957780; Email: d.katsaras@nhs.net
      • Contact: Khalid Abozguia, PhD; Phone Number: 00441253957780; Email: k.abozguia@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal ECGs; Patients with normal ECGs	Device: Alivecor recording; Alivecor recording and ECG recording from the same patient in very close temporal proximity
Active Comparator: Abnormal ECGs; 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.	Device: Alivecor recording; Alivecor recording and ECG recording from the same patient in very close temporal proximity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Blackpool Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Khalid Abozguia, Ph.D., Blackpool Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Anticipated): October 7, 2020
• Study Completion (Anticipated): October 7, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 22, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: IRAS Project ID:245687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes