Arrhythmias, CardiacCARMELNCT03826225
Cardiac Monitor Employee Study
An observational study of Arrhythmias, Cardiac, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories. 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
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 23 May 2019
- 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: This study will enroll volunteer adult participants who are employees of the study sponsor and who meet all eligibility criteria.
Who may be able to join
- Willing and capable to provide informed consent
- Age 18 or above
- Employee of the study sponsor
- Willing and able to follow protocol requirements
Who cannot join
- Currently enrolled in another clinical study that interferes with data collection
- Currently implanted with an active medical electronic device
- Known allergies to the materials that may come in contact with the skin
- Any active skin condition on the chest reported by the subject
Trial locations and contacts
1 site in 1 country.
About this study
This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.
Read the detailed description
The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data generated by the wearable cardiac monitor.
- Conditions
- Arrhythmias, Cardiac
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate WCM System End-To-End Performance
Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start7 Mar 2019
- Primary completion23 May 2019
- Study completion23 May 2019
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.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Perschbacher, Principal investigator, Senior R&D Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826225
- Sponsor's protocol ID
- CARMEL
- Acronym
- CARMEL
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Monitor Employee Study
- ClinicalTrials.gov ID
- NCT03826225
- Acronym / sponsor ID
- CARMEL / CARMEL
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 1 Feb 2019 (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.
This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.
Detailed description
The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data generated by the wearable cardiac monitor.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll volunteer adult participants who are employees of the study sponsor and who meet all eligibility criteria.
Key inclusion criteria (4 listed)
- Willing and capable to provide informed consent
- Age 18 or above
- Employee of the study sponsor
- Willing and able to follow protocol requirements
Key exclusion criteria (4 listed)
- Currently enrolled in another clinical study that interferes with data collection
- Currently implanted with an active medical electronic device
- Known allergies to the materials that may come in contact with the skin
- Any active skin condition on the chest reported by the subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate WCM System End-To-End Performance
Time frame: 3 months
Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Dave Perschbacher principal investigator
Senior R&D Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Boston Scientific Corporation at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate WCM System End-To-End Performance (time frame: 3 months). 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 8 Jul 2019.