Cardiac Arrhythmia
Conditions
Keywords
Ambulatory electrocardiographic monitoring, Arrhythmia detection
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.
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.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC | 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. |
| Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC | 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. |
| Concordance of Supraventricular Tachycardia Episodes Greater Than 3 Beats Between Frontier X Plus and MoMe ARC | 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. |
| Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC | 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. |
| Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC | 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. |
| Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC | 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. |
| Atrial Fibrillation Burden Detected by Frontier X Plus and MoMe ARC | 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. |
Countries
United States
Contacts
CONTACTElizabeth Dineen, DO
PRINCIPAL_INVESTIGATORElizabeth Dineen, DO
Mayo Clinic
Outcome results
None listed