Skip to main content
OpenTrials
Completed

NCT Number: NCT07158333

Mobile Cardiac Telemetry (MCT) 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orange County Research Center

Lake Forest, California, 92630, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Mobile Cardiac Telemetry (MCT System)

Device

MCT System without data transmission

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 30 days

    skin and adhesive comfort, and device stability and skin contact

  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.

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.