DF4 Master Study (Safety and Efficacy Study)

Master Study of the BIOTRONIK DF4 System

The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.

Inclusion Criteria:

• Patient has provided written informed consent.
• Patient has standard ICD/CRT-D indication.
• Patient accepts Home Monitoring concept.
• Patient is able to attend the planned hospital follow-up visits.
• Patient has legal capacity and ability to consent.

Exclusion Criteria:

• Patient has a standard contra-indication for ICD/CRT-D therapy.
• Age < 18 years
• Patient is pregnant or breastfeeding.
• Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months.
• Life expectancy of less than 12 months.
• Participating in any other clinical study of an investigational cardiac drug or device.