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Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)

NCT07772817

RecruitingN/A

Sponsor: Mayo Clinic

Conditions: Cardiac Arrhythmia

Interventions: Frontier X Plus chest-strap ECG device, MoMe ARC ambulatory ECG monitor

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (3)

Scottsdale, Arizona, United States
Jacksonville, Florida, United States
Rochester, Minnesota, United States