NCT05529654

IMpella-Protected cArdiaC Surgery Trial (IMPACT)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective single-armed Trial to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients. A concurrent Registry will also be performed to collect information on patients meeting Exclusion Criteria and those not approached for enrollment. The overall aim is to evaluate if using Impella 5.5 peri-operatively improves early hemodynamics, end-organ function and subsequent clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.

Conditions

• Left Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	Impella 5.5 with SmartAssist	For subjects enrolled in the Trial, the Impella 5.5 will be placed intra-operatively during the index cardiac surgical procedure

Timeline

• Start date: 2023-09-21
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-09-07
• Last updated: 2025-07-28

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study