12 Lead ECG Database

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Diagnostic test: 12-Lead ECG and home sleep study (HST) diagnostics

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jill Fricke, BS; Phone Number: 1-888-726-7239; Email: jill.fricke@huxleymed.com
• Study Contact Backup: Name: Brennan Torstrick, PhD; Phone Number: 1-888-726-7239; Email: brennan@huxleymed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Huxley Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 19, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CP-10002 12 Lead ECG Database

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes