Cardiac ArrhythmiaNCT07772817
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 of Cardiac Arrhythmia, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Frontier X Plus chest-strap ECG device and MoMe ARC ambulatory ECG monitor
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to 23 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Elizabeth Dineen, DO
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kathryn Larson, MD, 507-293-6358
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Satyajit Reddy, MD
About this study
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
- Being tested
- Frontier X Plus chest-strap ECG device, MoMe ARC ambulatory ECG monitor
- Keywords
- Ambulatory electrocardiographic monitoring, Arrhythmia detection
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Frontier X Plus chest-strap ECG device; Device: MoMe ARC ambulatory ECG monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth H. Dineen, Mayo Clinic
- Investigators
- Elizabeth Dineen, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772817
- Sponsor's protocol ID
- 25-012842
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No