Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)
14 september 2026 bijgewerkt door: Elizabeth H. Dineen, Mayo Clinic
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
15
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Elizabeth Dineen, DO
- Telefoonnummer: 904-953-5230
- E-mail: dineen.elizabeth@mayo.edu
Studie Locaties
-
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85259
- Werving
- Mayo Clinic Arizona
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Contact:
- Satyajit Reddy, MD
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- Werving
- Mayo Clinic Florida
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Contact:
- Elizabeth Dineen, DO
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Werving
- Mayo Clinic Rochester
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Contact:
- Kathryn Larson, MD
- Telefoonnummer: 507-293-6358
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
The MoMe ARC monitor will be used as the traditional ambulatory ECG comparator and processed according to standard clinical workflows.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
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24 hours
|
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Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
|
24 hours
|
|
Concordance of Supraventricular Tachycardia Episodes Greater Than 3 Beats Between Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
|
24 hours
|
|
Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
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24 hours
|
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Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
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24 hours
|
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Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
|
24 hours
|
|
Atrial Fibrillation Burden Detected by Frontier X Plus and MoMe ARC
Tijdsspanne: 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.
|
24 hours
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elizabeth Dineen, DO, Mayo Clinic
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
23 februari 2027
Studie voltooiing (Geschat)
23 februari 2027
Studieregistratiedata
Eerst ingediend
14 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 augustus 2026
Eerst geplaatst (Werkelijk)
19 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
14 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25-012842
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .