Clinical Trial

IMpella-Protected cArdiaC Surgery Trial (IMPACT)

Study acronym: IMPACT
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-09-02; most recent amendment 2026-05-08.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-07-24
Status change: Not Yet Recruiting → Enrolling by Invitation 2023-09-26
Trial Details
NCT Number NCT05529654
Lead Sponsor Abiomed Inc.
Conditions Left Ventricular Dysfunction
Enrollment 100 participants
Start Date 2023-09-21
Primary Completion 2025-11-04 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-12