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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Active Adults Undergoing Ambulatory ECG Monitoring2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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