European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)
European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)
BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD
 and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result
 in a more efficient FU and cost-savings for the health care payer.

 The EuroEco study:

 1. Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic
 consultations and regular check ups of the patient/ICD/CRT-D data received through the
 HM service.

 2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and
 CRT-D patients versus the traditional FU.

 3. Compares the indicators of patients' safety between the two FU models.
The EuroEco is a prospective, international, randomized study aimed at assessing the economic
 effects of BIOTRONIK Home Monitoring (HM) technology as compared with traditional follow up
 (FU) of ICD and 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. The study
 outlines a new model for the FU of ICD-and CRT-D patients based on a combination of in-clinic
 consultations and regular check ups of the patient data received through the HM service.

 About 312 patients with an indication for ICD therapy and 104 patients with an indication for
 de novo CRT-D implantation should be enrolled. All patients will be implanted with BIOTRONIK
 ICD or CRT-D devices from the Lumax families and randomized (1:1) to the traditional, or to
 HM-based FU model. Traditional FU will be performed according to the local clinical practice.
 Patients in the HM study arm will first undergo local clinical FU routine until the first
 in-clinic visit after patient discharge. Thereafter routine in-clinic FUs are scheduled at 12
 and 24 months. Three HM data checks should be carried out during each 12-month interval, to
 assess the patient/ICD/CRT-D status remotely.

 In both (HM and no HM) groups, additional in-hospital FU may be scheduled any time the
 patients reports symptoms which are presumed to be cardiovascular symptoms. In the HM group,
 additional in-clinic FU may also be scheduled as a result of specific HM findings.

 The following FU-related activities were accounted for: in-clinic consultations, patients
 contact, discussion with colleague physician, nurse or technician and arranging in clinic
 consultation. In HM patients, two additional HM-related FU activities were taken into
 account: 1) checking the website of BIOTRONIK HM Service Center, and 2) checking HM-related
 emails and faxes (provided by BIOTRONIK HM Service Center)..

 Several tools were made available to document the time that physicians, nurses and
 technicians spend with these FU activities without disrupting their clinical routine much:

 -  designated case report forms

 -  a web-based time measurements software.

 A user manual for time measurements was handed out to physicians, nurses and technicians to
 recommend which tool should be used in which clinical situation. The average time per patient
 followed according to the traditional FU model and the average time per patient followed by
 the HM-based FU model will be calculated for each of the three health care professionals
 considered (physicians, nurses and technicians). The difference in costs between the
 traditional and the HM-based FU will be assessed for statistical significance.

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

 -  Indication for 1-/2- chamber ICD implantation, including replacement indication

 -  Patient is willing and able to comply with the clinical investigation plan and has
 provided written informed consent

 ICD Patient Population - Exclusion Criteria

 -  Patients with contraindication to ICD implantation

 -  Patients with indication for cardiac resynchronization (CRT)

 -  Minors and pregnant women

 -  Patients participating in another study

 CRT-D Patient Population - Inclusion Criteria

 -  Patients with indication for de novo CRT-D implantation according to current
 guidelines

 -  Patient is willing and able to comply with the clinical investigation plan and has
 provided written informed consent

 CRT-D Patient Population - Exclusion Criteria

 -  Patients who had a cardiac device implanted before (upgrade, device replacement)

 -  Life expectancy less than 12 months

 -  Planned heart transplantation

 -  NYHA IV

 -  Minors < 18 years

 -  Pregnant and breast-feeding women

 -  Participation in another clinical study