Remote Cardiac Monitoring by the Corsano CardioWatch 287-2 Evaluation Study

Wearables have the potential to monitor patients remotely. The Corsano
CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation
and long-term blood pressure. The device has been validated using clinical
trials in hospitals, but validation in the intended remote setting is lacking.

Primary objective: To compare the number of episodes of atrial fibrillation
detected by the Corsano CardioWatch 287-2 during 28 days of use with the number
of episodes of atrial fibrillation detected by conventional Holter monitoring
during 48 hours of use (standard care).
Secondary objective: To assess the difference in blood pressure measurements
obtained by the Corsano CardioWatch 287-2 and the conventional cuff blood
pressure monitor over a period of 28 days; to assess the usability of the
Corsano CardioWatch 287-2 from a patient perspective; to assess the difference
between awake-asleep blood pressure change as measured by the Corsano
CardioWatch 287-2 and awake-asleep blood pressure change as measured by a
conventional 30-min. oscillometric blood pressure cuff across 24 hours.

Group A:
Conventional 24 hour EKG holter monitoring will be compared to 28 day
continuous monitoring by the Corsano CardioWatch 287-2 to assess whether the
percentage of patients in whom atrial fibrillation is detected will increase.
Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by
optical photoplethysmography (PPG), after which atrial fibrillation is
confirmed with a 30-second ECG measurement.
Additionally, conventional cuff blood pressure will be compared to blood
pressure measured by the Corsano CardioWatch 287-2 to validate free-living
blood pressure monitoring. Patients will measure their blood pressure daily
with a cuff blood pressure measurement device. The measurements at day 7, 14,
21 will be used to reinforce the Corsano blood pressure algorithm. The
remaining measurements will be used to compare the blood pressure with the
values measured by the Corsano CardioWatch 287-2 to assess accuracy.

Group B:
Conventional automatic cuff blood pressure measurement will be compared with
the Corsano CardioWatch 287-2 for 24-48 hours. The automatic cuff blood
pressure monitor will take a blood pressure reading every 30 minutes. Each
reading will be compared with the Corsano CardioWatch 287-2 reading.

At the cardiologist's office, Group A and B patients receive 3 blood pressure
measurements. These are performed by a nurse. Group A will take daily blood
pressure readings of themselves at home. If atrial fibrillation is detected by
the wristband, Group A patients will be asked to take an ECG. Finally, Group A
patients will be asked once to complete a questionnaire. Group B only has to
wear the wristband for 24 to 48 hours as an additional burden in addition to
the aforementioned initial measurements.