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Purpose

The purpose of this research is to compare the standard ambulatory ECG monitor, the MoMe ARC, against Fourth Frontier's "Frontier X Plus". This device is an FDA-Cleared chest-strap-based ECG wearable that provides an alternative modality to capture ambulatory ECG rhythm changes.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult participants (>22 years; Frontier X is approved for use in this age group) who participate in >4 days a week of >150 minutes total per week of moderate to high intensity exercise who were prescribed a ambulatory ECG monitor for clinical purposes for 24 hours or more. - Patients must agree to wear the Frontier X monitor for the prescribed duration and use the Frontier X Plus application

Exclusion Criteria

  • Current use of Implanted Cardiac Devices - Pregnancy - Known allergies to any of the materials listed in the "List of Patient-Contacting Materials" - Presence of skin injuries or broken skin in the area where the chest strap is worn - Inability to use a compatible mobile device required for the operation of the study device - Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures - Medical restrictions on exercise for safety including cardiac, orthopedic or other relevant past medical history

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Active Adults Undergoing Ambulatory ECG Monitoring Participants prescribed clinical ambulatory ECG monitoring will wear the Frontier X Plus chest-strap ECG device simultaneously with the MoMe ARC traditional ambulatory ECG monitor during their prescribed monitoring period and typical daily activities, including exercise.
  • Device: Frontier X Plus chest-strap ECG device
    The Frontier X Plus is a chest-strap-based wearable ECG device with embedded dry electrodes and a sensor that captures, stores, analyzes, and transmits ECG data through a mobile application and cloud-based platform for subsequent review.
  • Device: MoMe ARC ambulatory ECG monitor
    The MoMe ARC monitor will be used as the traditional ambulatory ECG comparator and processed according to standard clinical workflows.

Recruiting Locations

Mayo Clinic Arizona
Scottsdale, Arizona 85259
Contact:
Satyajit Reddy, MD

Mayo Clinic Florida
Jacksonville, Florida 32224
Contact:
Elizabeth Dineen, DO

Mayo Clinic Rochester
Rochester, Minnesota 55905
Contact:
Kathryn Larson, MD
507-293-6358

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Elizabeth Dineen, DO
904-953-5230
dineen.elizabeth@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.