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Cardiac ArrhythmiaNCT07772817

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 of Cardiac Arrhythmia, run by Mayo Clinic at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Cardiac Arrhythmia
What is being tested?
Frontier X Plus chest-strap ECG device and MoMe ARC ambulatory ECG monitor
Type of treatment
Medical device
How many people
15 participants
Where
3 sitesUnited States
Study dates
Sep 2026to 23 Feb 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Dineen, DO contact

904-953-5230

dineen.elizabeth@mayo.edu

United States3 sites, 3 recruiting
  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Elizabeth Dineen, DO

    Recruiting
  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Kathryn Larson, MD, 507-293-6358

    Recruiting
  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Satyajit Reddy, MD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Frontier X Plus chest-strap ECG device, MoMe ARC ambulatory ECG monitor
Keywords
Ambulatory electrocardiographic monitoring, Arrhythmia detection
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Frontier X Plus chest-strap ECG deviceDevice

    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 monitorDevice

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

Study groups in NCT07772817
Study groupRoleWhat they receive
Active Adults Undergoing Ambulatory ECG MonitoringParticipants 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.
Receives: Device: Frontier X Plus chest-strap ECG device; Device: MoMe ARC ambulatory ECG monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completion23 Feb 2027 (estimated)
  4. Study completion23 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07772817
Sponsor's protocol ID
25-012842
Status last verified
Sep 2026
First submitted
14 Aug 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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