Mobile Cardiac Telemetry (MCT) Study

NCT ID: NCT07158333

Last Updated: 2025-11-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-05

Study Completion Date

2025-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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MCT device subjects

All subjects are provided MCT system

Mobile Cardiac Telemetry (MCT System)

Intervention Type DEVICE

MCT System without data transmission

Interventions

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Mobile Cardiac Telemetry (MCT System)

MCT System without data transmission

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Each subject must meet the following criteria to be enrolled in this study:

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

1. Unable to comply with the study protocol and instructions for wearing the MCT Patch for up to 30 days.
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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orange County Research Center

Lake Forest, California, United States

Site Status

Countries

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United States

Other Identifiers

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BXU607689

Identifier Type: -

Identifier Source: org_study_id