Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2025-08-05
2025-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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MCT device subjects
All subjects are provided MCT system
Mobile Cardiac Telemetry (MCT System)
MCT System without data transmission
Interventions
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Mobile Cardiac Telemetry (MCT System)
MCT System without data transmission
Eligibility Criteria
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Inclusion Criteria
1. Subject is ≥18 years of age.
2. Completes the consent process as required.
3. Subject can speak and read English fluently.
4. Subject is willing to allow shaving of device application area, as required.
5. Subject is willing and able to take photos of the application area before, during, and immediately after wear of each Adhesive Patch
Exclusion Criteria
2. Geographically located such that they cannot have the initial MCT Patch placed by PI or designee.
3. 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.
4. Had any sternal incision or wound within 3 months prior to the date of enrolment.
5. Subjects with sensitive skin or known skin conditions, including known allergies.
6. Subjects with scheduled cardioversion during the data collection period.
7. Subjects with a scheduled electronic imaging (including magnetic resonance imaging) during the data collection period.
8. 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).
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Locations
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Orange County Research Center
Lake Forest, California, United States
Countries
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Other Identifiers
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BXU607689
Identifier Type: -
Identifier Source: org_study_id