Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Analysis of cell and protein deposits on the Impella Heart Pump.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impella CP | Patients treated with Impella CP heart pump for more than 4 days due to severe acute heart failure by any cause | ||
| Impella 5.5 | Patients treated with Impella 5.5 heart pump for more than or equal to 25 days due to severe acute heart failure by any cause |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Investigate deposits and biomaterial after use of pump | investigate Impella CP after use regarding deposits and biomaterial | through study completion, at least 5 days |
| Investigate deposits and biomaterial after use of pump | investigate Impella 5.5 pumps after use regarding deposits and biomaterial | through study completion, at least 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relation deposits and biomaterial to clinical events | 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. | through study completion, at least 5 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated with Impella CP or Impella 5.5 heart pump due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis or in relation to cardiac surgery).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirstin Starke, Director | Contact | +49 241 88600 | RA-PumpReturnEMailAr@ITS.JNJ.com | |
| Christian Cremer, CPM | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Pia Lanmüller, MD | Deutsches Herzzentrum der Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg | Not yet recruiting | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
No publication planned yet
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Relation deposits and biomaterial to clinical events | By correlating patient data, such as medical history and Impella 5.5 related blood parameters, with the findings from our pump analysis, potential connections between medication, diseases, comorbidities, and deposits on the pump can be identified. | through study completion, at least 25 days |
| Universitätsklinikum Düsseldorf | Not yet recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
|
| Herzzentrum Dresden | Not yet recruiting | Dresden | Saxony | 01307 | Germany |
|
| Herzzentrum Leipzig | Not yet recruiting | Leipzig | Saxony | 04289 | Germany |
|
| Deutsches Herzzentrum der Charité Berlin | Recruiting | Berlin | 13353 | Germany |
|
| Uniklinik Köln | Not yet recruiting | Cologne | 50937 | Germany |
|
| Westdeutsches Herz- und Gefäßzentrum Essen | Not yet recruiting | Essen | 45147 | Germany |
|