Clinical Validation of the AliveCor Kardia 12L and 6L Devices
Primary Purpose
Arrhythmia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kardia 12L
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 18 years old or older
- Ability to sit for an ECG and AliveCor Kardia 12L and Kardia 6L recordings for 20 minutes
Exclusion Criteria:
- Any internal stimulator that would generate electrical interference with the recording system of the AliveCor Kardia 12L or Kardia 6L.
- 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 both devices 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 both devices as well as 12-lead ECG for each study participant
Agreement on QT interval between Kardia 12L and ECG
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05053243
First Posted
September 13, 2021
Last Updated
April 26, 2023
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT05053243
Brief Title
Clinical Validation of the AliveCor Kardia 12L and 6L Devices
Official Title
Clinical Validation of the AliveCor Kardia 12L and 6L Devices
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2021 (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 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.
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
100 (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 V2 and V4 in a sequential fashion along with the Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 7 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 both devices 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 both devices as well as 12-lead ECG for each study participant
Time Frame
30 seconds
Title
Agreement on QT interval between Kardia 12L and ECG
Description
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
Time Frame
30 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female patients 18 years old or older
Ability to sit for an ECG and AliveCor Kardia 12L and Kardia 6L recordings for 20 minutes
Exclusion Criteria:
Any internal stimulator that would generate electrical interference with the recording system of the AliveCor Kardia 12L or Kardia 6L.
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
Study Director
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 of the AliveCor Kardia 12L and 6L Devices
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