12 Lead ECG Database

NCT06513637 | Not Yet Recruiting FDA Device

• 1 other identifier: CP-10002 12 Lead ECG Database
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• No specified primary endpoint

  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.

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects will receive the same treatment; there are no groups or cohorts that receive different treatments. Study populations at each site will be enrolled from patients, site personnel, or the general population. Recruitment may, from time to time, target enrichment of a particular demographic, subject characteristic, or cardiac arrhythmia to increase the diversity and representation of the database.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huxley Medical, Inc.: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Jill Fricke, BS

CONTACT

1-888-726-7239; jill.fricke@huxleymed.com

Brennan Torstrick, PhD

CONTACT

1-888-726-7239; brennan@huxleymed.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share