Mobile Cardiac Telemetry (MCT) Study

NCT07158333 | Completed FDA Device

• 1 other identifier: BXU607689
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

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

  30 days

Secondary Outcomes (2)

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

  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.

  From enrollment to end of study at 30 days.

Study Arms (1)

MCT device subjects

All subjects are provided MCT system

Device: Mobile Cardiac Telemetry (MCT System)

Interventions

Mobile Cardiac Telemetry (MCT System) DEVICE

MCT System without data transmission

MCT device subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: August 5, 2025
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)