• Average number of in-hospital follow-up visits per patient [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
• Time to first in-hospital follow-up visit beyond the first post-implantation visit [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Effective financial impact on hospitals / physicians [ Time Frame: 26 months ] [ Designated as safety issue: No ]
• Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions) [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
• Proportion of patients with HM-triggered interventions that, without remote monitoring, would have first been discovered at a subsequent scheduled follow-up [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
• Incidence of inappropriate ICD shocks [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
• Changes in quality-of-life (SF-36) from baseline to the 12- and to 24-month follow-up visits [ Time Frame: 26 months ] [ Designated as safety issue: No ]

BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their patients with implanted cardioverter-defibrillators (ICDs) 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 patients that combines in-clinic consultations and regular check ups of the patient/ICD data received through the HM service.
2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD 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 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-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 should be enrolled. All patients will be implanted with BIOTRONIK single- or dual-chamber ICD devices from the Lumos and 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 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
• BlackBerry cell phones.

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 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).

• Ventricular Fibrillation
• Tachycardia, Ventricular
• Ventricular Flutter

• Device: Home Monitoring provided by Biotronik ICD devices
• Device: No Home Monitoring

• Experimental: Remote monitoring of ICD function and patient status
• Active Comparator: Home Monitoring option is switched off

Inclusion Criteria:

• Indication for single- or dual-chamber ICD, including device replacement
• Patient willing and able to comply with the clinical investigation plan (informed consent)

Exclusion Criteria:

• Indication for cardiac resynchronization therapy
• Pregnant and breast feeding women
• Participation in another clinical study