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

NCT07772817 | Recruiting FDA Device

• 1 other identifier: 25-012842
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cardiac Arrhythmia

Keywords

Ambulatory electrocardiographic monitoring; Arrhythmia detection

Outcome Measures

Primary Outcomes (7)

• 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.

  24 hours

• 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.

  24 hours

• 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.

  24 hours

• 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.

  24 hours

• 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.

  24 hours

• 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.

  24 hours

• 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.

  24 hours

Study Arms (1)

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

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.

Active Adults Undergoing Ambulatory ECG Monitoring

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.

Active Adults Undergoing Ambulatory ECG Monitoring

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Dineen, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Dineen, DO

CONTACT

904-953-5230; dineen.elizabeth@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)