ClinicalTrials.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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Arrhythmias, Cardiac by Mayo Clinic — 2 open to participants now, 3 under way, none of them phase 3. Arrhythmias, Cardiac · Mayo Clinic.

Started
2026
the only one that year
Observational
5 of 11
2 open now
Registered
11th of 11
by date

Among the 11 studies in Arrhythmias, Cardiac by Mayo Clinic, this one is the only one that started in 2026, is one of 5 observational ones, and was the 11th registered.

Arrhythmias, Cardiac

1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

Browse Arrhythmias, Cardiac studies →

Open to participants now

2 of the 11 studies in Arrhythmias, Cardiac by Mayo Clinic are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.

This study: 22 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Cardiac Arrhythmia

Keywords

  • Ambulatory electrocardiographic monitoring
  • Arrhythmia detection
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

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.

06

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

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.

Of 189 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 140. This study's planned 5 months is below that.

Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2026
First posted
Aug 19, 2026
StartEst.
Sep 2026
Primary completionEst.
Feb 23, 2027
CompletionEst.
Feb 23, 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

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