CClinicalTrials.gg
RecruitingNCT07772817Updated Sep 17, 2026

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

An observational study in Cardiac Arrhythmia, sponsored by Mayo Clinic. Recruiting at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Arrhythmia

Browse trials for

Keywords

  • Ambulatory electrocardiographic monitoring
  • Arrhythmia detection
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Active adults older than 22 years who participate in moderate- to high-intensity exercise at least 4 days per week and more than 150 minutes per week total, and who have been prescribed ambulatory ECG monitoring for clinical purposes for 24 hours or more.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · Device: MoMe ARC ambulatory ECG monitor

Interventions

  • DeviceFrontier 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.

  • DeviceMoMe ARC ambulatory ECG monitor

    The MoMe ARC monitor will be used as the traditional ambulatory ECG comparator and processed according to standard clinical workflows.

05

What researchers measure

Primary outcomes

  1. Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for symptomatic triggered events. Results will be reported as the number of symptomatic triggered event findings for which the Frontier X Plus and MoMe ARC reports are in agreement.

    Time frame: 24 hours

  2. Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for ventricular tachycardia episodes greater than 3 beats. Results will be reported as the number of ventricular tachycardia episode findings for which the Frontier X Plus and MoMe ARC reports are in agreement.

    Time frame: 24 hours

  3. Concordance of Supraventricular Tachycardia Episodes Greater Than 3 Beats Between Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for supraventricular tachycardia episodes greater than 3 beats. Results will be reported as the number of supraventricular tachycardia episode findings for which the Frontier X Plus and MoMe ARC reports are in agreement.

    Time frame: 24 hours

  4. Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Total time in atrial fibrillation will be assessed for each device and reported as the cumulative duration of atrial fibrillation detected during the concordant monitoring period.

    Time frame: 24 hours

  5. Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for premature atrial contraction counts. Results will be reported as the number of premature atrial contraction count findings for which the Frontier X Plus and MoMe ARC reports are in agreement.

    Time frame: 24 hours

  6. Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for premature ventricular contraction counts. Results will be reported as the number of premature ventricular contraction count findings for which the Frontier X Plus and MoMe ARC reports are in agreement.

    Time frame: 24 hours

  7. Atrial Fibrillation Burden Detected by Frontier X Plus and MoMe ARC

    Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Atrial fibrillation burden will be assessed for each device and reported as the percentage of the concordant monitoring period during which atrial fibrillation was detected.

    Time frame: 24 hours

06

Study locations

3 of 3 sites recruiting
  • Mayo Clinic Arizona
    Scottsdale, Arizona 85259, United States
    • Satyajit Reddy, MD · Contact
    Recruiting
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
    • Elizabeth Dineen, DO · Contact
    Recruiting
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
    • Kathryn Larson, MD · Contact · 507-293-6358
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07772817
Lead sponsor
Mayo Clinic
Responsible party
Elizabeth H. Dineen (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Aug 19, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 23, 2027 (estimated)
Completion
Feb 23, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Elizabeth Dineen, DO
Contact
dineen.elizabeth@mayo.edu
904-953-5230
Elizabeth Dineen, DO
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion