Heart FailureNCT06765226
Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps
An observational study of Heart Failure, run by Abiomed Inc. at 7 sites in Germany.
Trial summary
Analysis of cell and protein deposits on the Impella Heart Pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 200 participants
- Where
- 7 sitesGermany
- Study dates
- 21 Sep 2025to 31 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- Age < 18 years
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Cremer, CPM contact
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Deutsches Herzzentrum der Charité Berlin
Berlin, 13353
Pia Lanmüller, MD
- Not yet recruiting
Uniklinik Köln
Cologne, 50937
llija Djordjevic, MD
- Not yet recruiting
Herzzentrum Dresden
Dresden, Saxony, 01307
Norman Mangner, MD
- Not yet recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Amin Polzin, MD
- Not yet recruiting
Westdeutsches Herz- und Gefäßzentrum Essen
Essen, 45147
Payam Akhyari, MD
- Not yet recruiting
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Anna Meyer, MD
- Not yet recruiting
Herzzentrum Leipzig
Leipzig, Saxony, 04289
Michael Borger, MD
About this study
Official title: Abiomed Impella Pump Return Registry - Observational Study
Analysis of cell and protein deposits on the Impella Heart Pump.
Read the 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate deposits and biomaterial after use of pump
investigate Impella CP after use regarding deposits and biomaterial
Measured: 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
Measured: through study completion, at least 25 days
Secondary outcomes (2)
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.
Measured: through study completion, at least 5 days
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.
Measured: through study completion, at least 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start21 Sep 2025
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pia Lanmüller, MD, Principal investigator, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765226
- Sponsor's protocol ID
- 2024-R01
- Status last verified
- Sep 2025
- First submitted
- 2 Jan 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No publication planned yet
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abiomed Impella Pump Return Registry - Observational Study
- ClinicalTrials.gov ID
- NCT06765226
- Acronym / sponsor ID
- 2024-R01
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2025 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigate deposits and biomaterial after use of pump
Time frame: through study completion, at least 5 days
investigate Impella CP after use regarding deposits and biomaterial
Investigate deposits and biomaterial after use of pump
Time frame: through study completion, at least 25 days
investigate Impella 5.5 pumps after use regarding deposits and biomaterial
2 secondary outcomes
Relation deposits and biomaterial to clinical events
Time frame: through study completion, at least 5 days
Relation deposits and biomaterial to clinical events
Time frame: through study completion, at least 25 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided. No publication planned yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Cremer, CPM contact
Pia Lanmüller, MD principal investigator
Deutsches Herzzentrum der Charité
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abiomed Inc. at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirstin Starke, Director (+49 241 88600, RA-PumpReturnEMailAr@ITS.JNJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate deposits and biomaterial after use of pump (time frame: through study completion, at least 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.