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

Abiomed

Status: Enrolling

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT06765226

2024-R01

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Impella CP

Description:

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

Impella 5.5

Description:

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