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CompletedNCT07158333Updated Nov 12, 2025

Mobile Cardiac Telemetry (MCT) Study

An observational study in Healthy, sponsored by Baxter Healthcare Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.

Sponsored by Baxter Healthcare Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

Each subject must meet the following criteria to be enrolled in this study:

  1. Subject is ≥18 years of age.
  2. Completes the consent process as required.
  3. Subject can speak and read English fluently.
  4. Subject is willing to allow shaving of device application area, as required.
  5. Subject is willing and able to take photos of the application area before, during, and immediately after wear of each Adhesive Patch

Exclusion criteria

Exclusion Criteria:

  1. Unable to comply with the study protocol and instructions for wearing the MCT Patch for up to 30 days.
  2. Geographically located such that they cannot have the initial MCT Patch placed by PI or designee.
  3. 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.
  4. Had any sternal incision or wound within 3 months prior to the date of enrolment.
  5. Subjects with sensitive skin or known skin conditions, including known allergies.
  6. Subjects with scheduled cardioversion during the data collection period.
  7. Subjects with a scheduled electronic imaging (including magnetic resonance imaging) during the data collection period.
  8. 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).
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • MCT device subjects

    All subjects are provided MCT system

    Device: Mobile Cardiac Telemetry (MCT System)

Interventions

  • DeviceMobile Cardiac Telemetry (MCT System)

    MCT System without data transmission

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

Secondary outcomes

  1. Subject Self-Reported Log & Subject Survey of the MCT Patch after 30 days

    skin and adhesive comfort, and device stability and skin contact

    Time frame: 30 days

  2. 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.

06

Study locations

1 site
  • Orange County Research Center
    Lake Forest, California 92630, United States
07

Registry details

Key details

Study ID
NCT07158333
Lead sponsor
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Sep 5, 2025
Start date
Aug 5, 2025
Primary completion
Sep 12, 2025
Completion
Sep 12, 2025
Last update
Nov 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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