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

NCT05617001 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-28

No results posted yet for this study

Summary

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

Interventions

DEVICE

Kardia 12L

The purpose of this study is to collect clinical validation data to support an FDA submission for a 510(k) for the Kardia 12L hardware which enables the simultaneous diagnostic quality recording of all 6 limb leads and any chest lead. We will be recording both Leads V1 and V2 in a sequential fashion along with the V4 and Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 5 leads into a complete 12-lead ECG. The 12-lead ECG used for validation of the recordings and the 12-lead synthesis model is the GE Cardiosoft System which is FDA cleared.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Stavros Stavrakis, MD, PhD · University of Oklahoma

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2024-08-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617001 on ClinicalTrials.gov