Analyzing deposits and biomaterial on returned Impella pumps.
Abiomed Impella Pump Return Registry - Observational Study
This project will analyze cell and protein buildup on Impella heart pumps removed from adult patients who had prolonged support to see if longer use leads to more deposits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abiomed Inc. Industry-sponsored |
| Locations | 7 sites (Heidelberg, Baden-Wurttemberg and 6 other locations) |
| Trial ID | NCT06765226 on ClinicalTrials.gov |
What this trial studies
This observational project collects Impella pumps explanted after clinical use and examines the nature and amount of cell and protein adhesion. Pumps returned from adult patients (Impella 5.5 for ≥25 days or Impella CP for >4 days) at three German centers will be analyzed and correlated with duration of support. The analysis will use microscopic, histologic, and biochemical techniques to characterize deposits and any patterns associated with prolonged use, including bridge-to-transplant scenarios. Findings aim to fill gaps left by preclinical tests and inform device handling and future design improvements.
Who should consider this trial
Good fit: Adults (≥18 years) who received Impella 5.5 support for 25 or more days or Impella CP support for more than 4 days and whose devices can be returned for analysis are ideal candidates.
Not a fit: Patients under 18, those with short-duration Impella support, or those treated outside the participating centers whose pumps cannot be returned are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, findings could help improve safe long-term use of Impella pumps and guide changes in device management or design to reduce complications.
How similar studies have performed: Preclinical biocompatibility testing has shown general device safety, but detailed clinical data on long-duration deposits are limited, making this clinical analysis relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heidelberg, Baden-Wurttemberg and 6 other locations
- Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Not_yet_recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Not_yet_recruiting)
- Herzzentrum Dresden — Dresden, Saxony, Germany (Not_yet_recruiting)
- Herzzentrum Leipzig — Leipzig, Saxony, Germany (Not_yet_recruiting)
- Deutsches Herzzentrum der Charité Berlin — Berlin, Germany (Recruiting)
- Uniklinik Köln — Cologne, Germany (Not_yet_recruiting)
- Westdeutsches Herz- und Gefäßzentrum Essen — Essen, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Pia Lanmüller, MD — Deutsches Herzzentrum der Charité
- Study coordinator: Kirstin Starke, Director
- Email: RA-PumpReturnEMailAr@ITS.JNJ.com
- Phone: +49 241 88600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.