12 Lead ECG Database

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

12-Lead ECG and home sleep study (HST) diagnostics

Diagnostic Test

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.

Primary outcomes

No specified primary endpoint

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brennan Torstrick, PhD

CONTACT

[email protected]

1-888-726-7239

Jill Fricke, BS

CONTACT

[email protected]

1-888-726-7239

Sponsors and collaborators

Lead sponsor

Huxley Medical, Inc.

Industry

Registry information

Official study title

12-Lead ECG Database

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 22, 2024
Registry last updated: Jul 22, 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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