ONGOING CLINICAL TRIAL

Impella-Protected Cardiac Surgery Trial (IMPACT)

Trial Objective:

To determine the safety and efficacy of using Impella 5.5® with SmartAssist® preemptively in high-risk cardiac surgery patients with severe LV dysfunction by evaluating hemodynamics, end organ function and clinical outcomes. Patients included are undergoing elective or urgent cardiac surgery procedures on cardiopulmonary bypass.

Arm: Impella 5.5 with SmartAssist

Inclusion Criteria

Top Five Exclusion Criteria

Complete exclusion criteria can be found at: https://www.clinicaltrials.gov/study/NCT05529654

Additional exclusion criteria and important clinical trial design information: https://www.abiomed.com/important-safety-information

 

IMP-5159

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