Multi-Centre Based Study Recognition Of Atrial Fibrillation With The Corsano CardioWatch 287-2 System

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* 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 Criteria:

* 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;

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 09/09/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Suraj Kapa

Contact us for the latest status

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available