NCT07772817Recruiting
Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)
Mayo Clinic
Start Date
9/1/2026
Completion Date
2/23/2027
Summary
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 Criteria
Age Range: 22 years to No maximum
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
Interventions
DEVICE
Frontier X Plus chest-strap ECG device
DEVICE
MoMe ARC ambulatory ECG monitor
Conditions
Cardiac Arrhythmia
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States