Log in
Enquire now
‌

Clinical Validation of the AliveCor Kardia 12L and 6L Devices

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT05053243
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT050532430
Trial Recruitment Size
1000
Trial Sponsor
University of Oklahoma
University of Oklahoma
0
Clinical Trial Start Date
September 27, 2021
0
Primary Completion Date
October 31, 2023
0
Study Completion Date
December 31, 2023
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Diagnostic0
Interventional Trial Phase
Not Applicable0
Participating Facility
University of Oklahoma Health Sciences Center
University of Oklahoma Health Sciences Center
0
Official Name
Clinical Validation of the AliveCor Kardia 12L and 6L Devices0
Last Updated
April 27, 2023
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
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 two new devices: Kardia 12L and Kardia 6L to record 12- lead and 6-lead ECGs, respectively. However, the data generated from the two new devices have not yet been validated for accuracy. The purpose of this study is to evaluate the accuracy of the ECGs recorded by AliveCor Kardia 12L and 6L devices. This will be compared to simultaneous standard of-care 12-lead ECG recordings. The ECGs will be analyzed for accuracy and statistical difference using root-mean-square error and cross correlation between the median beats.

Timeline

No Timeline data yet.

Further Resources

Title
Author
Link
Type
Date
No Further Resources data yet.

References

Find more entities like Clinical Validation of the AliveCor Kardia 12L and 6L Devices

Use the Golden Query Tool to find similar entities by any field in the Knowledge Graph, including industry, location, and more.
Open Query Tool
Access by API
Golden Query Tool
Golden logo

Company

  • Home
  • Press & Media
  • Blog
  • Careers
  • WE'RE HIRING

Products

  • Knowledge Graph
  • Query Tool
  • Data Requests
  • Knowledge Storage
  • API
  • Pricing
  • Enterprise
  • ChatGPT Plugin

Legal

  • Terms of Service
  • Enterprise Terms of Service
  • Privacy Policy

Help

  • Help center
  • API Documentation
  • Contact Us
By using this site, you agree to our Terms of Service.