Heart Failure, Tachyarrhythmia
Conditions
Brief summary
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
Interventions
DEVICEPamira ICD lead family
Implantation, measurements and follow-up schedule
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pamira lead related SADE-d free rate at 6 months after implantation | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation | 3 months, 12 months |
| 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up | 6 months, 12 months |
| 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up | 6 months, 12 months |
Countries
Australia, Austria, Belgium, Germany, Hungary, Israel, Latvia, Slovakia
Outcome results
None listed