Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System

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A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akik szívritmusvizsgálaton esnek át, vagy már van náluk ismert szívritmuszavar, egy szívritmust figyelő csuklópánt kipróbálásához.

Életkor

22 éves vagy idősebb

Nem

Bármely nem részt vehet.

A betegség stádiuma

Szívritmuszavarra utaló tünetekkel élők, akik 24-48 órás EKG Holter vagy 12 elvezetéses EKG vizsgálatot kapnak, vagy korábban szívritmuszavart diagnosztizáltak náluk, és rutin kontrollra érkeznek.

A részvétel fő kizáró okai

• Nem tudja viselni a Corsano CardioWatch 287 eszközt (például allergia, sebek, amputáció miatt)
• Nem tud vagy nem akar EKG-monitorozáson részt venni
• Nem tudja vagy nem akarja aláírni a beleegyező nyilatkozatot
• Olyan egészségi állapot, amely a vizsgáló szerint veszélyeztetné a biztonságát, vagy akadályozná a vizsgálat befejezését
• Nem tud írni, olvasni és beszélni hollandul vagy angolul

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter.

A vizsgálat 4 csoportja

• Group A: patients receiving 24-48 hour holter monitoring as standard of care

  Holter monitoring will be compared to continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration of AF episodes detected by the investigational device correspond to an ECG-holter reference across various demographic groups. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation can be confirmed with a 30-second ECG measurement. Additionally, all participants will be asked to perform 10 single-lead ECG's with the investigational device at standard timepoints (every 2 hours when awake), and when AF is detected (minimal 30 minutes time difference between alerts) across the 24-48 hours.

  Kezelés: Corsano CardioWatch 287-2

• Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up

  Patients with a known diagnosis of (paroxysmal) atrial fibrillation presenting to the clinic for routine follow-up evaluation will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A, these patients will also be asked to perform manual ECG measurements with the investigational device. Group B was added to ensure that a considerable amount of the included data includes periods with atrial fibrillation. As the results of a prior study (RECAMO study NCT05899959) show that the amount of patients in Group A with periods of atrial fibrillation is limited (7.0%).

  Kezelés: Corsano CardioWatch 287-2

• Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation

  Patients with a known diagnosis of (paroxysmal) atrial fibrillation registered in a patient organisation for patients with AF will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A and B, these patients will also be asked to perform manual ECG measurements with the investigational device. For this group two (virtual) visits will be scheduled before (visit a) and after (visit b) the study period. In visit a) additional information regarding the study will be provided and potential alarm signals will be screened to ensure the patient does not participate in the trial in case direct medical attention is required. If the patient does not show any alarm signals they will be asked to provide informed consent. Once informed consent is provided all materials will be mailed to them via postal services after which they can perform the measurements and return the materials via postal

  Kezelés: Corsano CardioWatch 287-2

• Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.

  Participants in this group will wear the CardioWatch 287-2 during the standard 12-lead ECG recordings conducted in the outpatient clinic. Patients will be asked to perform a manual ECG spot-check with the investigational device during (if not feasible directly before), and immediately following the 12-lead ECG. Furthermore, the CardioWatch 287-2 will be worn for at least 5 minutes prior to and following the 12-lead ECG. Although these recordings are brief, this group was included to enhance the study population's size and demographic diversity while minimizing the burden on both patients and hospital staff. This group is expected to consist of both non-AF and AF patients, providing valuable insights into the investigational device's performance in a setting similar to its intended real-world application.

  Kezelés: Corsano CardioWatch 287-2