A European, prospective, multicenter, post-market clinical single-arm follow-up trial with an adaptive design.~The study will first include up to 123 patients, but the adaptive mechanism can allow the sample size to increase up to 535 patients.~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 improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.
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.