12 Lead ECG Database
ConditionArrhythmias, Cardiac
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuxley Medical, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
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 hoursLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: