Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)

AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right finger(s) on the right electrode and the left finger(s) on the left electrode, an electrical circuit is completed and a lead-I, 30 second rhythm strip is created. KardiaMobile and a newer device, KardiaMobile 6L, were approved by FDA for ECG rhythm recording. Recently, AliveCor developed a new device: Kardia 12L to record 12-lead ECGs. However, the data generated from the new device has not yet been validated for accuracy. The specific aim of this study is to evaluate the accuracy and safety of the AC 12L ECG System. The ECGs collected by the AC 12L ECG System will be compared to simultaneous standard- of-care 12-lead ECG, recorded using the GE CardioSoft 12-lead ECG System. The ECGs will be analyzed for accuracy based on statistical difference using root-mean-square error, and cross correlation between the simultaneous 10 second recordings as well as the median beats of all 12 leads.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Kardia 12L

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Stout, RN; Phone Number: 44761 405-271-9060; Email: michael-h-stout@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Sciences Center
      • Contact: Michael Stout, RN; Phone Number: 44761 405-271-9060; Email: michael-h-stout@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female patients 18 years or older
• Ability to remain supine for a conventional 12 lead AliveCor 12L ECG recording for approximately 15 minutes

Exclusion Criteria:

• Open chest wounds or recent (<30 days) surgery to the chest or abdomen
• Absence of any limb that would require modification of the lead set-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement on QRS width between Kardia 12L and ECG	Quantitative analysis on QRS width will be performed on the median-beat ECGs derived from the recorded ECGs from the device as well as 12-lead ECG for each study participant	30 seconds
Agreement on PR interval between Kardia 12L and ECG	Quantitative analysis on PR interval will be performed on the median-beat ECGs derived from the recorded ECGs from the device as well as 12-lead ECG for each study participant	30 seconds
Agreement on AT interval between Kardia 12L and ECG	Quantitative analysis on AT interval will be performed on the median-beat ECGs derived from the recorded ECGs from the device as well as 12-lead ECG for each study participant	30 seconds

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Stavros Stavrakis, MD, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: PRO-0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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