Heart Failure
Conditions
Brief summary
Analysis of cell and protein deposits on the Impella Heart Pump.
Detailed description
The Impella heart pump supports patients in cardiogenic shock for various reasons and has passed safety and biocompatibility evaluations. The planned investigation aims to further analyze cell and protein adhesion on these pumps and the effects of their prolonged use, especially in scenarios like bridge-to-transplant, recognizing preclinical testing limitations.
Interventions
None listed
Sponsors
Abiomed Inc.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Impella 5.5 therapy and duration of support for ≥ 25 days OR Patients with Impella CP therapy and duration of support for \> 4 days
Exclusion criteria
* Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigate deposits and biomaterial after use of pump | through study completion, at least 5 days | investigate Impella CP after use regarding deposits and biomaterial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relation deposits and biomaterial to clinical events | through study completion, at least 5 days | By correlating patient data, such as medical history and Impella CP related blood parameters, with the findings from our pump analysis, potential connections between medication, diseases, comorbidities, and deposits on the pump can be identified. |
Countries
Germany
Contacts
Primary ContactKirstin Starke, Director
Backup ContactChristian Cremer, CPM
Outcome results
None listed