Clinical Validation of the AliveCor Kardia 12L and 6L Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 221
- Locations
- 2
- Primary Endpoint
- Agreement on QRS width between Kardia 12L and ECG
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Agreement on QRS width between Kardia 12L and ECG
Time Frame: 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
Agreement on PR interval between Kardia 12L and ECG
Time Frame: 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
Agreement on QT interval between Kardia 12L and ECG
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported