Clinical Trial

IMPACT EU Post-Market Clinical Follow-Up Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated September 30, 2025 (before its estimated August 8, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-03-03; most recent amendment 2025-09-29.
Status change: Recruiting → Active, Not Recruiting 2025-09-29
Status change: Not Yet Recruiting → Recruiting 2023-04-28
Trial Details
NCT Number NCT05756751
Lead Sponsor Abiomed Inc.
Conditions Left Ventricular Dysfunction
Enrollment 123 participants
Start Date 2023-04-27
Primary Completion 2026-08-08 (estimated)
Study Completion 2026-08-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-30