Mobile Cardiac Telemetry (MCT) Study

Baxter

Status: Completed

Conditions: Healthy

Treatments: Device: Mobile Cardiac Telemetry (MCT System)

Study type: Observational

Funder types: Industry

Identifiers

NCT07158333

BXU607689

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

15 participants in 1 patient group

MCT device subjects

Description:

All subjects are provided MCT system

Treatment:

Device: Mobile Cardiac Telemetry (MCT System)