NCT05756751

IMPACT EU Post-Market Clinical Follow-Up Study

IMpella®-Protected cArdiaC Surgery Trial in Europe: A European, Prospective, Multicenter, Post-Market Clinical Follow-Up Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Left Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	Device: Impella 5.5 with SmartAssist	Patients who are deemed high-risk due to low preoperative ejection fraction undergoing cardiac surgery with cardiopulmonary bypass (CPB) which will be supported by the Impella 5.5 System.

Timeline

• Start date: 2023-04-27
• Primary completion: 2026-08-08
• Completion: 2026-08-08
• First posted: 2023-03-06
• Last updated: 2025-09-30

Locations

13 sites across 2 countries: Czechia, Germany

Regulatory

• FDA-regulated device study