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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-Lead ECG and home sleep study (HST) diagnostics | Diagnostic Test |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jill Fricke, BS | Contact | 1-888-726-7239 | jill.fricke@huxleymed.com | |
| Brennan Torstrick, PhD | Contact | 1-888-726-7239 | brennan@huxleymed.com |
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No IPD will be shared to other researchers.
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D004568 | Electrodiagnosis |