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

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kardia 12L

Device

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 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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Sep 22, 2021
Registry last updated: Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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