Analyzing deposits and biomaterial on returned Impella pumps.
Official title: Abiomed Impella Pump Return Registry - Observational Study
Run by Abiomed Inc. · NCT06765226 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Abiomed Inc. Industry-sponsored |
| Locations | 7 sites (Heidelberg, Baden-Wurttemberg and 6 other locations) |
| Status | Recruiting |
| Started | September 21, 2025 |
| Main results expected | July 31, 2030 |
| Study ends | January 31, 2031 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT06765226 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Preclinical biocompatibility testing has shown general device safety, but detailed clinical data on long-duration deposits are limited, making this clinical analysis relatively novel.
Who can join: the full rules
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 it's running
-
Deutsches Herzzentrum der Charité Berlin
Berlin, Germany Recruiting -
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 -
Uniklinik Köln
Cologne, Germany Not yet recruiting
Show 1 more location
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.