NCT06513637

12 Lead ECG Database

12-Lead ECG Database

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Huxley Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	12-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.

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-07-22
• Last updated: 2024-07-22

Regulatory

• FDA-regulated device study