Status:
NOT_YET_RECRUITING
Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
Lead Sponsor:
Corsano Health B.V.
Conditions:
Atrial Fibrillation (AF)
Paroxysmal Atrial Fibrillation (PAF)
Eligibility:
All Genders
22+ years
Brief 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 wri...
Detailed Description
Rationale: Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation. The device has been validated using ...
Eligibility Criteria
Inclusion
- Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation
- Age ≥ 22 years old
- Able to provide informed consent.
- Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.
Exclusion
- Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable or not willing to receive ECG monitoring;
- Unable or not willing to sign informed consent;
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06955273
Start Date
May 1 2025
End Date
January 1 2026
Last Update
May 2 2025
Active Locations (1)
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1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625AD