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.
Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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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.
Ran from Aug 2025 to primary completion in Sep 2025, 1 month.
How these figures are worked out, and which studies are left out of them.
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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