Multi-Centre based study Recognition of Atrial Fibrillation with the Corsano CardioWatch 287-2 System.

AF is the most common cardiac arrhythmia and is associated with increased
morbidity and mortality due to thromboembolic complications. AF can fluctuate
over time and may be asymptomatic or episodic. Therefore, accurate and
continuous monitoring of AF is crucial for optimal diagnosis, treatment, and
prevention of cardiovascular events.

However, conventional methods for measuring AF have several limitations. AF
detection usually relies on electrocardiography (ECG), which records the
electrical activity of the heart. However, ECG requires electrodes attached to
the chest or limbs, which can be uncomfortable or inconvenient for long-term
monitoring. Moreover, ECG may miss paroxysmal or silent AF episodes that occur
sporadically or without symptoms.

Wearable devices are emerging as a promising alternative to conventional
methods for measuring AF. Wearable devices can measure AF continuously and
non-invasively by using novel sensors and algorithms that do not require a cuff
or electrodes. Wearable devices can also enable remote monitoring and data
transmission to health care providers or researchers. However, wearable devices
need to be evaluated against standard methods in different clinical settings
and patient populations.

The Corsano CardioWatch 287-1 is a CE-MDR certified and clinically validated
vital signs monitoring bracelet. It is able to continuously measure pulse rate,
inter-beat intervals, breathing rate , sleep and activity. The Corsano
CardioWatch 287-2, an iteration on the 287-1, adds electrocardiogram (ECG),
oxygen saturation (SpO2), galvanic skin response (GSR), core body temperature
and non-invasive blood pressure (NIBP).

The Corsano CardioWatch Corsano 287-2 has been submitted to laboratory tests
against internationally recognized standards for the monitoring of pulse rate,
respiratory rate, SpO2, GSR, temperature and ECG. Additionally, the RECAMO
(NL83281.000.22) study has been performed to investigate the performance in a
non-controlled remote care setting. However, due to the nature of the study few
periods with (paroxysmal) AF became available. Furthermore, all data was
collected in a single centre with a low variety in demographics and
ethnicities.

The current trial aims to assess and validate atrial fibrillation detection and
monitoring by the Corsano CardioWatch 287-2 in a remote setting across multiple
international centres.

By:
a) To compare episodes of atrial fibrillation across 30-second intervals
detected by the Corsano CardioWatch 287-2 with episodes of atrial fibrillation
detected by conventional Holter monitoring across 24-48 hours or short
in-clinic 12-lead ECG based on the positive predictive value, negative
predictive value, sensitivity and specificity.
b) Comparing the number of atrial fibrillation episodes greater than 6 minutes,
1 hour, 6 hours, and 12 hours duration detected by the CardioWatch 287-2 and
with the number of these specific episodes detected by conventional Holter
across 24-48 hours days. As well as to assess primary outcomes in light of
demographic subgroups, patient activity and the signal quality index.

This concerns a multi-center, single-arm, diagnostic accuracy study. Four
different groups of patients will be approached for participation in the trial:


Group A:
ECG holter monitoring will be compared to continuous monitoring by the Corsano
CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration
of AF episodes detected by the investigational device correspond to an
ambulatory ECG reference across various demographic groups. Detection of atrial
fibrillation with the Corsano CardioWatch 287-2 is done by optical
photoplethysmography (PPG), after which atrial fibrillation can be confirmed
with a 30-second ECG measurement. Additionally, all participants will be asked
to perform 10 single-lead ECG*s at standard timepoints (every 2 hours when
awake) across the 24-48 hours.

Group B:
Patients with a known diagnosis of (paroxysmal) atrial fibrillation presenting
to the clinic for routine follow-up evaluation will be asked to eligibly
participate in ambulatory ECG monitoring as well as continuous monitoring by
the Corsano CardioWatch 287-2 across 24-48 hours.
Group B was added to ensure that a considerable amount of the included data
includes periods with atrial fibrillation. As the results of a prior study
(RECAMO study NL83281.000.22) show that the amount of patients in Group A with
periods of atrial fibrillation is limited (7.0%).

Group C:
Patients with a known diagnosis of (paroxysmal) atrial fibrillation registered
in a patient organisation for patients with AF will be asked to eligibly
participate in ambulatory ECG monitoring as well as continuous monitoring by
the Corsano CardioWatch 287-2 across 24-48 hours. For this group two (virtual)
visits will be scheduled before (visit a) and after (visit b) the study period.
In visit a) additional information regarding the study will be provided and
potential alarm signals will be screened to ensure the patient does not
participate in the trial in case direct medical attention is required. If the
patient does not show any alarm signals they will be asked to provide informed
consent. Once informed consent is provided all materials will be mailed to them
via postal services after which they can perform the measurements and return
the materials via postal services. In visit b) the results will be provided to
the patient, and if necessary the patient will be recommended to seek medical
attention.

Group D:
Participants in this group will wear the CardioWatch 287-2 during the standard
12-lead ECG recordings conducted in the outpatient clinic. Patients will be
asked to perform a manual ECG spot-check with the investigational device during
(if not feasible directly before), and immediately following the 12-lead ECG.
Furthermore, the CardioWatch 287-2 will be worn for at least 5 minutes prior to
and following the 12-lead ECG. Although these recordings are brief, this group
was included to enhance the study population's size and demographic diversity
while minimizing the burden on both patients and hospital staff. This group is
expected to consist of both non-AF and AF patients, providing valuable insights
into the investigational device's performance in a setting similar to its
intended real-world application.

Groups C and D were added to limit the additional workload for hospital staff
and ensure inclusion of a diverse patient population from different demographic
and ethnical groups.

The study involves wearing of the Corsano CardioWatch 287-2 and a standard
ECG-holter for 24-48 hours or short in-clinic 12-lead ECG, which does not
impose a significant risk to the patient but does call on the patient's time
and effort. The study is necessary for the evaluation of the Corsano
CardioWatch 287-2 in a remote care setting across a variaty of demographic
groups. The device has the potential to improve the monitoring of atrial
fibrillation, which can help prevent strokes and provide additional monitoring
strategies for atrial fibrillation. This potential can only be realized by
conducting the study and having patients wear the wristband as well as a
12-lead ECG-holter at home.