12 Lead ECG Database

Not yet recruiting

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT06513637
• Lead Sponsor: Huxley Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study Start: 2024-07-19
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.