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NCT Number: NCT07772817

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

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frontier X Plus chest-strap ECG device

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

Device

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

Primary outcomes

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Dineen, DO

CONTACT

[email protected]

904-953-5230

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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