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
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.
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.
Each subject must meet the following criteria to be enrolled in this study:
Exclusion Criteria:
All subjects are provided MCT system
Device: Mobile Cardiac Telemetry (MCT System)
MCT System without data transmission
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
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
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.
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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Baxter Healthcare Corporation