European Health Economic Trial on home monitoring in ICD and CRT-D patients

Remote monitoring of CRT-D function and patient status via *Home
Monitoring* (HM) offers the potential benefit of more
effective follow-up and increased safety through prevention of potential
deleterious events. Moreover, it could allow for more efficient follow-up, with
potential costsavings or the health care payer. It requires however a new
follow-up model
with fewer patients seen during routine in hospital consultations but with
systematic and regular remote follow-up.
Such a new model may have an important impact on both costs and income of
physicians and hospitals
(via reimbursement).
For physicians and hospitals, the cost of follow-up is comprised of personnel
cost (dependent on the time spent by physicians and paramedics), overhead costs
for space and personnel used, and technology-related costs. Income will be
defined by the existing reimbursement regulations. With current reimbursement
policies in most countries, however, the economic impact of HM for physicians /
hospitals may be negative (due to reduced income for routine follow-up visits).

For the payer of health care services, the total sum of follow-up related
reimbursement will constitute the cost side
of the equation (including rehospitalisation costs). Effectiveness for the
health care provider will depend on the quality of
the follow-up, as can be measured by e.g. mortality, average number of
in-hospital visits per patient and proportion of these
with relevant findings, HM-triggered interventions, patient QOL, or incidence
of inappropriate ICD shocks. HM may lead to
an improved cost-effectiveness for the health care provider, largely through a
reduction of costs.

The current approved version of the protocol (version 1.1 dd14NOV2007) has
enrolled his 312 subjects with a single- or double-chamber ICD. Currently more
and more triple-chamber ICDs are routinely implanted (CRT-D: ICD with Cardiac
Resynchronization Therapy) however no scientific data is available on the cost
effectiveness of the use of telemonitoring in this CRT patient population.
Therefore the current version of the protocol (version 1.1 dd14NOV2007) wil be
amanded to include 104 subjects with an CRT-D indication (protocol version 1.2
dd16FEB2012).

This amendmentl may provide data warranting a change in the guidelines for use
of CRT-D devices featuring HM, in that HM functionality may justify a
prolongation of the time interval between statutory routine in-clinic FU
visits. This, coupled with the fact that the information provided by HM helps
physicians recognize some otherwise unsuspected needs for additional FU visits,
may ultimately result in better and more cost-effective health care for all
involved ( patients, providers and payers).

This amendment (extension to CRT-D subjects) aims to assess the economic
effects of HM technology vs. classical follow-up of CRT-D patients from two
perspectives: 1) the cost-effectiveness for the payer of health care, and 2)
the economic impact on the physician, hospital and patient.

Patient follow-up will be managed according to a pre-defined algorithm based on
previous BIOTRONIK trial data aiming
at reducing in-hospital visits as much as possible while retaining maximal
effectiveness and safety.

Prospective.
Multicenter.
International.
Randomized (1:1).
Open-label.


All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D
device.
Patients will be randomized to HM=ON or HM=OFF.

-

All patients are indicated for a CRT-D ( BIOTRONIK Lumax HF-T).
All devices used are CE-marked. No additional risks are related to ICD
implantation due to study participation. No deviation from the currently common
therapy standard is to be expected due to study participation (with or without
Home Monitoring/ HM= On or HM=OFF).

The Quality Of Life (SF-36 QOL) will be evaluated 3 times during the 2 year
study period (baseline, 12 and 24 month follow up).