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

Mayo Clinic15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Arrhythmia

Interventions

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

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.

Central Contacts

Elizabeth Dineen, DO

CONTACT

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

Data from ClinicalTrials.gov

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