Ongoing and Upcoming Trials

The intent of the PROTECT IV RCT is to leverage and validate the best practices that we have learned over the past 10 years in the PROTECT series and cVAD studies that led to the exclusive FDA PMA approval of Impella® for high-risk PCI.

It is an on-label, prospective, multi-center randomized controlled trial (RCT) that is designed to provide the level of clinical evidence needed to achieve a global Class I guideline recommendation for Impella in high-risk PCI in the future.

As shown in the chart below, PROTECT IV is part of the Impella CP clinical evidence pathway to a Class I clinical guideline/recommendation for high-risk PCI.

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Abiomed officially began the IMPACT trial in the United States on September 21, 2023. This trial is designed 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 in patients. This Trial will determine whether using Impella 5.5 with SmartAssist in this setting will result in an acceptable device-related safety profile.

The trial is a prospective, multi-center, single-arm trial that plans to enroll 100 patients, over the age of 18 and of any gender, undergoing elective or urgent cardiac surgery procedures on cardiopulmonary bypass. 

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