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

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.

NCT Number	NCT06955273
Lead Sponsor	Corsano Health B.V.
Conditions	Atrial Fibrillation (AF), Paroxysmal Atrial Fibrillation (PAF)
Enrollment	350 participants
Start Date	2025-05-01
Primary Completion	2026-01-01 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-02