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NCT Number: NCT06765226

Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps

Analysis of cell and protein deposits on the Impella Heart Pump.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Relation deposits and biomaterial to clinical events

    Time frame: through study completion, at least 5 days

    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.

  2. Relation deposits and biomaterial to clinical events

    Time frame: through study completion, at least 25 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Cremer, CPM

CONTACT

Kirstin Starke, Director

CONTACT

[email protected]

+49 241 88600

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

Abiomed Impella Pump Return Registry - Observational Study

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jan 9, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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