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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-21

Study Completion Date

2031-01-31

Brief Summary

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

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Detailed Description

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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

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Impella CP

Patients treated with Impella CP heart pump for more than 4 days due to severe acute heart failure by any cause

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pia Lanmüller, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum der Charité

Locations

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