Arrhythmias, CardiacNCT06513637
12 Lead ECG Database
An observational study of Arrhythmias, Cardiac, run by Huxley Medical, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- 12-Lead ECG and home sleep study (HST) diagnostics
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 19 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- 12-Lead ECG and home sleep study (HST) diagnostics
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-Lead ECG and home sleep study (HST) diagnosticsDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start19 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huxley Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513637
- Sponsor's protocol ID
- CP-10002 12 Lead ECG Database
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-Lead ECG Database
- ClinicalTrials.gov ID
- NCT06513637
- Acronym / sponsor ID
- CP-10002 12 Lead ECG Database
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Huxley Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
No specified primary endpoint
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 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No. No IPD will be shared to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Huxley Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Fricke, BS (1-888-726-7239, jill.fricke@huxleymed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No specified primary endpoint (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 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.