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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)

Sponsor
University of Oklahoma (Other)
Overall Status
Recruiting
CT.gov ID
NCT05617001
Collaborator
(none)
200
Enrollment
1
Location
5.8
Anticipated Duration (Months)
34.2
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 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.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
Actual Study Start Date :
Oct 4, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

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 the device 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 the device as well as 12-lead ECG for each study participant

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

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

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

  • Principal Investigator: 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:
NCT05617001
Other Study ID Numbers:
  • PRO-0012
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 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 Nov 15, 2022