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 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
15
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Elizabeth Dineen, DO
- Telefonnummer: 904-953-5230
- E-post: dineen.elizabeth@mayo.edu
Studieorter
-
-
Arizona
-
Scottsdale, Arizona, Förenta staterna, 85259
- Rekrytering
- Mayo Clinic Arizona
-
Kontakt:
- Satyajit Reddy, MD
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32224
- Rekrytering
- Mayo Clinic Florida
-
Kontakt:
- Elizabeth Dineen, DO
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Mayo Clinic Rochester
-
Kontakt:
- Kathryn Larson, MD
- Telefonnummer: 507-293-6358
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC
Tidsram: 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.
|
24 hours
|
|
Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
24 hours
|
|
Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC
Tidsram: 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.
|
24 hours
|
|
Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Elizabeth Dineen, DO, Mayo Clinic
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
23 februari 2027
Avslutad studie (Beräknad)
23 februari 2027
Studieregistreringsdatum
Först inskickad
14 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2026
Första postat (Faktisk)
19 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25-012842
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .