HealthyNCT07158333
Mobile Cardiac Telemetry (MCT) Study
An observational study of Healthy, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
This study will be a single center, single arm, open-label, prospective study to evaluate adhesive performance of the Bardy Diagnostics' (BardyDx) MCT Patch up to 30 days of wear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Mobile Cardiac Telemetry (MCT System)
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 12 Sep 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
- Adult, Older adult
Study population: A total of 10 healthy evaluable subjects (wearing and returning the test article) consisting of at least 5 males and 5 females is the desired sample size.
Who may be able to join
- Each subject must meet the following criteria to be enrolled in this study:
- Subject is ≥18 years of age.
- Completes the consent process as required.
- Subject can speak and read English fluently.
- Subject is willing to allow shaving of device application area, as required.
- Subject is willing and able to take photos of the application area before, during, and immediately after wear of each Adhesive Patch
Who cannot join
- Unable to comply with the study protocol and instructions for wearing the MCT Patch for up to 30 days.
- Geographically located such that they cannot have the initial MCT Patch placed by PI or designee.
- Any breached or compromised skin, skin rash, irritation or infection over the sternum (prior to the initial application) as reported by the subject and/or observed by the PI during initial application.
- Had any sternal incision or wound within 3 months prior to the date of enrolment.
- Subjects with sensitive skin or known skin conditions, including known allergies.
- Subjects with scheduled cardioversion during the data collection period.
- Subjects with a scheduled electronic imaging (including magnetic resonance imaging) during the data collection period.
- Subject has known cardiac arrhythmia conditions (Note: The PI will assess the subject during initial screening. If an arrhythmia is discovered during the subject will be deemed ineligible for participation in the study).
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Lake Forest, California, 92630
About this study
This study will be a single center, single arm, open-label, prospective study to evaluate adhesive performance of the Bardy Diagnostics' (BardyDx) MCT Patch up to 30 days of wear.
- Conditions
- Healthy
- Being tested
- Mobile Cardiac Telemetry (MCT System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Cardiac Telemetry (MCT System)Device
MCT System without data transmission
| Study group | Role | What they receive |
|---|---|---|
| MCT device subjects | All subjects are provided MCT system Receives: Device: Mobile Cardiac Telemetry (MCT System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative wear time
as measured by ECG readability sufficient for identification of the P and QRS waves; the total readable duration summed from each patch, measured from the start of the first day to the end
Measured: 30 days
Secondary outcomes (2)
Subject Self-Reported Log & Subject Survey of the MCT Patch after 30 days
skin and adhesive comfort, and device stability and skin contact
Measured: 30 days
Adverse events of relevance, including potential skin damage due to repeated removal and reapplication of the MCT Patch as determined by Investigator/designee from subject assessments including Subject Logs, Subject Surveys and photos.
Measured: From enrollment to end of study at 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start5 Aug 2025
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158333
- Sponsor's protocol ID
- BXU607689
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Cardiac Telemetry (MCT) Study
- ClinicalTrials.gov ID
- NCT07158333
- Acronym / sponsor ID
- BXU607689
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 5 Sep 2025 (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 study will be a single center, single arm, open-label, prospective study to evaluate adhesive performance of the Bardy Diagnostics' (BardyDx) MCT Patch up to 30 days of wear.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCT device subjects | – | Device: Mobile Cardiac Telemetry (MCT System)All subjects are provided MCT system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 10 healthy evaluable subjects (wearing and returning the test article) consisting of at least 5 males and 5 females is the desired sample size.
Key inclusion criteria (6 listed)
- Subject is ≥18 years of age.
- Completes the consent process as required.
- Subject can speak and read English fluently.
- Subject is willing to allow shaving of device application area, as required.
- Subject is willing and able to take photos of the application area before, during, and immediately after wear of each Adhesive Patch
Key exclusion criteria (8 listed)
- Unable to comply with the study protocol and instructions for wearing the MCT Patch for up to 30 days.
- Geographically located such that they cannot have the initial MCT Patch placed by PI or designee.
- Any breached or compromised skin, skin rash, irritation or infection over the sternum (prior to the initial application) as reported by the subject and/or observed by the PI during initial application.
- Had any sternal incision or wound within 3 months prior to the date of enrolment.
- Subjects with sensitive skin or known skin conditions, including known allergies.
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 |
|---|---|---|
| Mobile Cardiac Telemetry (MCT System)MCT System without data transmission | Device | MCT device subjects |
Primary outcome
Cumulative wear time
Time frame: 30 days
as measured by ECG readability sufficient for identification of the P and QRS waves; the total readable duration summed from each patch, measured from the start of the first day to the end
2 secondary outcomes
Subject Self-Reported Log & Subject Survey of the MCT Patch after 30 days
Time frame: 30 days
Adverse events of relevance, including potential skin damage due to repeated removal and reapplication of the MCT Patch as determined by Investigator/designee from subject assessments including Subject Logs, Subject Surveys and photos.
Time frame: From enrollment to end of study at 30 days.
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 12 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Baxter Healthcare 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 6 inclusion and 8 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 12 Nov 2025. 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?
Cumulative wear time (time frame: 30 days). 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 12 Nov 2025.