Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

BIO|MASTER.Pamira Study

Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by

• demonstrating clinical safety
• evaluating performance based on sensing and pacing assessment
• collecting additional data of interest to assess other aspects such as the handling and usability

Inclusion Criteria:

• Standard indication for ICD or CRT-D therapy according to clinical guidelines
• Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira
• Ability to understand the nature of the study and willingness to provide written informed consent
• Ability and willingness to perform all follow-up visits at the study site
• Ability and willingness to use the CardioMessenger and acceptance the BIOTRONIK Home Monitoring® concept

Exclusion Criteria:

• Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
• Known Dexamethasone acetate intolerance
• Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
• Less than 18 years old
• Pregnant or breast feeding
• Participating in another interventional clinical investigation
• Life-expectancy less than 12 months