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

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT06765226
• Lead Sponsor: Abiomed Inc.

Brief Summary

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-04-01
• Primary Completion: 2030-03-31
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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
• Use of Sodium Bicarbonate as a purge additive as permitted by the IFU

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigate deposits and biomaterial after use of pump	through study completion, at least 25 days	investigate Impella 5.5 pumps after use regarding deposits and biomaterial

Secondary Outcome Measures

Name	Time	Method
Relation deposits and biomaterial to clinical events	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.

Trial Locations

Locations (2)

Herzzentrum Dresden; 🇩🇪 Dresden, Saxony, Germany

Deutsches Herzzentrum der Charité Berlin; 🇩🇪 Berlin, Germany