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

Description

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.

Conditions

Arrhythmia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Arrhythmia
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Oklahoma,

Stavros Stavrakis, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

2024-12