Background of the 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.
Objective of the study:
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.
Study design:
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.
Study population:
Patients receiving a 24 hour EKG holter or an ambulant blood pressure device after
visiting the cardiologist's outpatient clinic.
Primary study parameters/outcome of the study:
Absolute percentage increase of patients in whom at least one event of atrial
fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring,
compared to a conventional EKG holter during 24-48 hours of monitoring.
Secundary study parameters/outcome of the study (if applicable):
Mean blood pressure difference and its SD between blood pressure measured by the
Corsano CardioWatch 287-2 and blood pressure measured by a conventional
oscillometric blood pressure cuff.
Usability of the Corsano CardioWatch 287-2 in a remote care setting as determined by
a questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness:
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.