Mobile Cardiac Telemetry (MCT) Study

Completed

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT07158333

Run by

Baxter Healthcare Corporation

People needed

15

Starts

2025-08-05

Expected to finish

2025-09-12

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Orange County Research Center — Lake Forest, California, United States

Full record on ClinicalTrials.gov

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