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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)

Primary Purpose

Arrhythmia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kardia 12L
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oklahoma Health Sciences Center

Outcomes

Primary Outcome Measures

Agreement on QRS width between Kardia 12L and ECG
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
Agreement on PR interval between Kardia 12L and ECG
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
Agreement on AT interval between Kardia 12L and ECG
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

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
April 26, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05617001
Brief Title
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
Official Title
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Kardia 12L
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement on QRS width between Kardia 12L and ECG
Description
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
Time Frame
30 seconds
Title
Agreement on PR interval between Kardia 12L and ECG
Description
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
Time Frame
30 seconds
Title
Agreement on AT interval between Kardia 12L and ECG
Description
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
Time Frame
30 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Stavrakis, MD, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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