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

Sponsor
University of Oklahoma (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05053243
Collaborator
(none)
100
Enrollment
1
Location
15.1
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Kardia 12L
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Validation of the AliveCor Kardia 12L and 6L Devices
Actual Study Start Date :
Sep 27, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Agreement on QRS width between Kardia 12L and ECG [30 seconds]

    Quantitative analysis on QRS width will be performed on the median-beat ECGs derived from the recorded ECGs from both devices as well as 12-lead ECG for each study participant

  2. Agreement on PR interval between Kardia 12L and ECG [30 seconds]

    Quantitative analysis on PR interval will be performed on the median-beat ECGs derived from the recorded ECGs from both devices as well as 12-lead ECG for each study participant

  3. Agreement on QT interval between Kardia 12L and ECG [30 seconds]

    Quantitative analysis on QT interval will be performed on the median-beat ECGs derived from the recorded ECGs from both devices as well as 12-lead ECG for each study participant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Male and female patients 18 years old or older

  2. Ability to sit for an ECG and AliveCor Kardia 12L and Kardia 6L recordings for 20 minutes

Exclusion Criteria:

  1. Any internal stimulator that would generate electrical interference with the recording system of the AliveCor Kardia 12L or Kardia 6L.

  2. Open chest wounds or recent (<30 days) surgery to the chest or abdomen.

  3. Absence of any limb that would require modification of the lead set-up

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104

Sponsors and Collaborators

  • University of Oklahoma

Investigators

  • Study Director: Stavros Stavrakis, MD, PhD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT05053243
Other Study ID Numbers:
  • 13692
First Posted:
Sep 22, 2021
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Jun 14, 2022