Atrial Fibrillation
Conditions
Brief summary
This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.
Detailed description
1. Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile. 2. Compare the ECG waveforms from the Smartwatch to the GE and KardiaMobile devices to demonstrate equivalence in terms of cross correlation (correlation coefficient \>.95) and RMS Difference (\<10 microvolts). 3. Compare the algorithmic determination from the Smartwatch ECG to those of the GE and KardiaMobile to demonstrate equivalence.
Interventions
DIAGNOSTIC_TESTWe propose to validate these smartwatch ECG functions to support FDA submissions
1\) Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
We propose to validate these smartwatch ECG functions to support FDA submissions
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female \> 18 years of age. * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. * Being seen in the OU Cardiac Electrophysiology Outpatient Clinic.
Exclusion criteria
* Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason. * Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRS amplitude | 30 seconds | Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile. |
Countries
United States
Outcome results
None listed