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

NCT06955273 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)
  • Paroxysmal Atrial Fibrillation (PAF)

Interventions

DEVICE

Corsano CardioWatch 287-2

Patients receive monitoring of their heart rhythm by the CardioWatch 287-2 next to monitoring of their heart rhythm by either a 24-48 holter or a short in-clinic 12-lead ECG monitoring.

Sponsors & Collaborators

  • Corsano Health B.V.

    lead INDUSTRY

Principal Investigators

  • Eelko Ronner, MD, PhD · Reinier de Graaf Groep

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-01-01
Completion
2026-01-31
FDA Device
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955273 on ClinicalTrials.gov