Arrhythmias, Cardiac
Conditions
Brief summary
The purpose of this investigation is to collect a database of simultaneous electrocardiogram (ECG) recordings from the SANSA device and a reference 12-lead ECG recording device. The purpose of this database is to aid development and evaluation of algorithms to detect cardiac arrhythmias and other parameters from the electrocardiogram. Example analyses that may utilize this database are ECG vector transformations and ECG waveform timing analyses. The study is for scientific purposes and does not intend to diagnose, cure, mitigate, treat, or prevent any disease and does not involve any medical procedures.
Interventions
DIAGNOSTIC_TEST12-Lead ECG and home sleep study (HST) diagnostics
* 12-lead ECG hookup will be performed following standard placement procedures. * The Home Sleep Study diagnostic device placement will be performed by study personnel following the manufacturer's instructions.
Sponsors
Huxley Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* are 18 years of age or older. * are able to read, understand, and sign informed consent documentation. * are willing to undergo simultaneous recordings with the Sansa and 12-lead ECG device.
Exclusion criteria
* exhibit deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would interfere with sensor placement * have broken or injured skin that would interfere with sensor placement * are known to experience adverse reactions to medical-grade adhesive * are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No specified primary endpoint | Subjects will participate in a single visit. Subjects will be considered enrolled upon signing the informed consent. The entire duration of enrollment is expected to be less than one hour and no more than six hours | This data collection protocol does not have any specific data analysis endpoints. Its purpose is to collect data to be included in an ECG database that may be used for various future analyses. The number, severity, and device/comparator relatedness of AEs reported while subjects undergo study procedures will be reported. |
Contacts
Primary ContactJill Fricke, BS
Backup ContactBrennan Torstrick, PhD
Outcome results
None listed