Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps
Abiomed Impella Pump Return Registry - Observational Study
1 other identifier
observational
200
1 country
7
Brief Summary
Analysis of cell and protein deposits on the Impella Heart Pump.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2025
CompletedStudy Start
First participant enrolled
September 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2031
October 3, 2025
September 1, 2025
4.9 years
January 2, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Relation deposits and biomaterial to clinical events
through study completion, at least 5 days
Relation deposits and biomaterial to clinical events
through study completion, at least 25 days
Study Arms (2)
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
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abiomed Inc.lead
Study Sites (7)
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Herzzentrum Dresden
Dresden, Saxony, 01307, Germany
Herzzentrum Leipzig
Leipzig, Saxony, 04289, Germany
Deutsches Herzzentrum der Charité Berlin
Berlin, 13353, Germany
Uniklinik Köln
Cologne, 50937, Germany
Westdeutsches Herz- und Gefäßzentrum Essen
Essen, 45147, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pia Lanmüller, MD
Deutsches Herzzentrum der Charité
Central Study Contacts
Christian Cremer, CPM
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2025
First Posted
January 9, 2025
Study Start
September 21, 2025
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
January 31, 2031
Last Updated
October 3, 2025
Record last verified: 2025-09