Heart Failure, Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
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.
Interventions
DEVICEIforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse device effect (SADE) rate related to the ICD with DF4 connection | until 3 month follow-up |
| SADE rate related to the Linox smart DF4 lead (ICD shock lead) | until 3 month follow-up |
| Shift rate of the painless shock impedance measurement | between 3 and 6 month follow-up |
| Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead | 3 month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of automatic atrial pacing threshold test vs. manual measurement | 3 month follow-up |
Countries
Germany
Outcome results
None listed