NCT06955273Not yet recruiting
Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Corsano Health B.V.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06955273
What you commit to
- Study type: Observational
- Planned participants: 350
- From 1 May 2025 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.;
Other
- Unable or not willing to receive ECG monitoring;
- Unable or not willing to sign informed consent;
Who the study is looking for
- 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.
Age in the registry: 22 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reinier de Graaf Gasthuis Coordinator of this site? Confirm its status | Delft | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.