IMPACT EU Post-Market Clinical Follow-Up Study

Status Recruiting

Clinical Trial Summary

The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.

Clinical Trial Description

A European, prospective, multicenter, post-market clinical single-arm follow-up trial. Up to 123 patients will be enrolled in the study. Patients will be followed for up to 1-year. The objectives of the study are to collect data on the safety and on the effectiveness of the Impella 5.5 System in mitigating post-cardiotomy cardiac failure, as well as improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05756751
Study type	Interventional
Source	Abiomed Inc.
Contact	Andreas Goetzenich, Prof. Dr. Dr.
Phone	+49 241 8860
Email	agoetzenich@abiomed.com
Status	Recruiting
Phase	N/A
Start date	April 27, 2023
Completion date	August 2025

View Details

See also
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