12 Lead ECG Database

NCT ID: NCT06513637

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-19

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmias, Cardiac

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huxley Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jill Fricke, BS

Role: CONTACT

1-888-726-7239

Brennan Torstrick, PhD

Role: CONTACT

1-888-726-7239

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP-10002 12 Lead ECG Database

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Obstructive Sleep Apnoea and Cardiac Arrhythmias
NCT03866148 ACTIVE_NOT_RECRUITING NA
FibriCheck Data Registry
NCT06282393 RECRUITING NA