Heart Failure, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
Interventions
DEVICESD01 ICD lead
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Standard indication for an ICD/CRT-D therapy * Signed informed consent form * Patient is willing and able to participate for the whole study duration * Patient is willing and able to activate and use the CardioMessenger * Legal capacity and ability to consent.
Exclusion criteria
* Standard contraindication for an ICD/CRT-D therapy * Age \<18 years. * Pregnant or breastfeeding * Cardiac surgery is planned within the next six months * Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period * Enrollment in another cardiac clinical investigation with active treatment arm * Mechanical tricuspid valve prosthesis or severe tricuspid valve disease * Dexamethasone acetate intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of appropriate sensing and pacing | at the 3-month follow-up | The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of capture at the end of the 3-month follow-up. |
| Serious adverse device effects (SADEs) related to the SD01 lead | until the 3-month follow-up | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of pacing threshold between Linoxsmart and SD01 | at the 3-month follow-up | Comparison of the manually measured pacing threshold of the SD01 lead system to the Linox SD lead at 3-month follow-up. The idea is that the pacing threshold will be similar within a suitable range. |
| Shift rate of the painless shock impedance measurement | between 3- and 6-month follow-up | — |
Countries
Czechia, France, Germany, Hungary, Latvia
Outcome results
None listed