documentation of lead movement patients with ICD therapy
Conditions
Interventions
None listed
Sponsors
BIOTRONIK SE & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: · Patient has provided written informed consent · Patient has a BIOTRONIK ICD or CRT-D · Patient has at least a BIOTRONIK Linoxsmart S-DX lead or any other BIOTRONIK lead model · Data about the implantation of the ICD/CRT-D, the lead(s) and the implanting physician are available at the investigation site · Patient is able to attend the X-ray procedure following a routine follow-up visit · None of the leads was implanted within the last three months · Patient had no cardiac intervention within the last two months · Patient has legal capacity and ability to consent
Exclusion criteria
Exclusion criteria: · Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No primary or secondary endpoints were defined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Data of interest in addition to the biplane cinefluoroscopy are: - Patient characteristics - ICD/CRT-D therapy characteristics, including data about implantation procedure - X-ray procedural data - Termination of individual patient study participation - Adverse and serious adverse events Exploratory data analyses will be used to describe the patient population. | — |
Countries
Netherlands
Outcome results
None listed