Recruiting

MoMe ARC vs. Frontier X Plus

Sponsor:

Mayo Clinic

Code:

NCT07772817

Conditions

Cardiac Arrhythmia

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Frontier X Plus chest-strap ECG device

MoMe ARC ambulatory ECG monitor

Study Details

Brief 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.

Conditions

Cardiac Arrhythmia

Study ID

NCT07772817

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]
  • Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]
  • Concordance of Supraventricular Tachycardia Episodes Greater Than 3 Beats Between Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]
  • Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]
  • Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]
  • Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]
  • Atrial Fibrillation Burden Detected by Frontier X Plus and MoMe ARC [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Elizabeth Dineen, DO

904-953-5230dineen.elizabeth@mayo.edu

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kathryn Larson, MD

507-293-6358

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Ambulatory electrocardiographic monitoring
  • Arrhythmia detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-19.