Heart Failure, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
ICD, CRT-D, Lead
Brief summary
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD 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
* Meet a standard indication for ICD/CRT-D therapy * First ICD/CRT-D implantation or upgrade from pacemaker * Signed informed consent form * Willing to participate for the whole duration of the registry * Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger * Patient has legal capacity and ability to consent
Exclusion criteria
* Meet a standard contraindication for an ICD/CRT-D therapy * Age \<18 years * Pregnant or breast-feeding women * Cardiac surgery planned within the next six months * 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 |
|---|---|
| SADE-free rate | 10 years |
Other
| Measure | Time frame |
|---|---|
| Sensing amplitude of SD01 | 3-month follow-up |
| Device deficiencies | 10 years |
| Long-term pacing impedance, pacing threshold, sensing amplitude and painless shock impedance of SD01 and other leads, if applicable | 10 years |
| Pacing threshold of SD01 | 3-month follow-up |
| ICD/CRT-D system performance | 10 years |
| SD01 implantation information, handling and operation time record | Implantation |
| Analysis of arrhythmias and their treatment | until 3-month follow-up |
Countries
Germany
Outcome results
None listed