• Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  

• Rehospitalizations due to worsening heart failure; Correlation of Home Monitoring values with the clinical status; Incidence and reasons for Home Monitoring based interventions; Home Monitoring workflow analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  

Hospital admissions or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as heart rhythm disturbances, daily physical activity of a patient, or mean heart rates.

The Home Monitoring™ capability offered by many BIOTRONIK implants has the potential to detect some of these trends early. During Home Monitoring surveillance, medical and technical data from an ICD or CRT device are sent to a modified mobile phone, the so-called Cardio Messenger. This device transmits the data via a mobile phone network to the BIOTRONIK service center. There, the data are put into an easily accessible form and can then be viewed by the physician online via the internet on a secure website. Additionally, the occurrence of heart rhythm disturbances or device problems will be transmitted by fax, SMS or email.

This unique system allows the attending physician to monitor each patient very closely and to react early enough to prevent worsening of heart failure at an early stage, to optimize therapy, and to secure the correct functioning of the implant.

The goal of IN-TIME is thus to analyze the impact of a regular Home Monitoring evaluation on the health status of heart failure patients receiving such an implant as part of their therapy.

A total of 620 patients with heart failure symptoms and a severely reduced pumping function receiving an ICD or a CRT-D device from up to 50 European clinical centers will be enrolled into the study. About 4 weeks after discharge from the implanting hospital, patients will be randomly assigned to prospective patient management by Home Monitoring or standard care groups. Patients in the Home Monitoring group will be monitored at least once per week, patients in the control group will not be monitored during the study, but their transmitted Home Monitoring data will be analyzed after their ending of participation in the study.

The health status of patients will be measured using the well established "Packer Score". This score is a combined measurement of death rates, hospital admission rates, heart failure symptom classification and quality of life. Patients will be classified at their end of study participation as worsened, unchanged, or improved based on these parameters. To this end, the health status of participating patients will be determined regularly during further outpatient follow ups. These will take place at regular intervals due to the standard care.

Additionally, some special parameters sent to the physician via Home Monitoring will be analyzed whether they could possibly predict an imminent worsening of a patient's health - leading to an unplanned hospital visit - so that it could perhaps be prevented in the future.

Patients remain within the study for 12 months after randomization or until their participation is ended prematurely, e.g. by withdrawal of their consent, a low data transmission rate, or death.