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.
Study Type
OBSERVATIONAL
Enrollment
15
MCT System without data transmission
Orange County Research Center
Lake Forest, California, United States
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.
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