Clinical Research Directory

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

Sponsor: Corsano Health B.V.

Summary

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. To ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited: * Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring * Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation. * Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF. * Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care. The secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.

Key Details

Conditions

Interventions

Locations (1)