Remote Monitoring of Heart Failure Patients with a Cardiovascular Implantable Electronic Device:
The Patient Perspective
(REMOTE-CIED study)

Cardiovascular implantable electronic device therapy, in particular implantable
cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT),
has gained increasing acceptance and is now implanted on a large scale in a
subgroup of patients with congestive heart failure (CHF). In order to reduce
the workload for the outpatient clinics, remote patient monitoring (RPM) has
become a widely used method to check on these patients. RPM systems can
interrogate the ICD/CRT-D device automatically and send the data from the
patients* home to the physician, thereby reducing in-clinic follow-ups. Studies
have shown that the remote monitoring of device and CHF parameters (i.e.,
sudden changes in weight, blood pressure and other clinical parameters) reduces
health care utilization, without impairing patient safety. However, whether
these RPM effects translate to improved patient-reported outcomes is uncertain,
and no study to date has examined the effect of clinical and psychological
factors on patient acceptance and satisfaction with RPM.

The primary objective of this study is:
to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up
only on patient-reported health status/quality of life after implantation with
an ICD/CRT-D device.

The secondary objectives are:
1) to identify subgroups of patients who are or are not satisfied with RPM due
to specific clinical and psychological factors
2) to investigate the cost-effectiveness of RPM + in-clinic follow-up compared
to in-clinic follow-up only

The study will be a multicenter, randomized controlled study. Patients will be
randomized to either RPM + in-clinic follow-up (RPM group) or in-clinic
follow-up only (In-Clinic group). Both groups will be asked to complete a set
of standardized and validated questionnaires at 5 time points (i.e., T0=1-2
weeks, T1=3 months, T2=6 months, T3=12 months, and T4=24 months
post-implantation). The RPM group will receive the LATITUDE® Patient
Management system 4-8 weeks after implantation. The In-Clinic group will visit
the outpatient clinic every 3-6 months, as part of standard clinical practice.
The RPM group will visit the outpatient clinic only at 12 and 24 months
post-implantation, the other check-ups will be performed remotely.

For this protocol the sponsor will use a registred/certified device (implant)
for all patients and compare 2 groups. Patients will be randomized to either

1. usual care with RPM *Remote patient monitoring* which is also
registered/certified
2. usual care without RPM.

The risk associated with participation in the study is negligible as two
different types of care as usual will be compared with each other. No specific
(invasive) study procedures will be performed that causes any safety risks. The
patient commitment is comprised of completing a set of questionnaires at five
time points. These questionnaires are handed to them at discharge from the
hospital after implantation (T0) or sent to them by mail (T1-T4). Patients will
fill in all questionnaires at home, which will take approximately 45 minutes
per time point.