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.

PROTECT IV was designed by the leaders and best clinical trialists in the field of cardiovascular medicine. 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 clinical evidence pathway to a Class I clinical guideline/recommendation for high-risk PCI.

Back to top.

The RECOVER IV Randomized Controlled Trial (RCT) will assess whether PCI, with Impella support initiated prior to the PCI, is superior to PCI without Impella in patients with AMI cardiogenic shock. RECOVER IV will be a prospective, two-arm trial. Patients will be randomized to receive either Impella pre-PCI or other treatment protocols, which can include any kind of non-Impella mechanical circulatory support. 

In the Impella arm, patients will receive Impella support incorporating best practices learned in studies of the Impella Quality database, validated in the National Cardiogenic Shock Initiative (NCSI) study, and shown to be replicable in the INOVA and J-PVAD studies. The control group will receive conventional treatments, including inotropes, vasopressors, the intra-aortic balloon pump and forms of mechanical circulatory support other than Impella.

The primary endpoint of RECOVER IV is all-cause mortality at 30 days, with secondary endpoints to include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, days alive out of the hospital at six months, recovery of left ventricular (LV) function, need for durable left ventricular assist device (LVAD) or heart transplant, and health-related quality of life as measured by responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year.

As shown in the chart below, RECOVER IV is part of the Impella clinical evidence pathway to a Class I clinical guideline recommendation for AMI cardiogenic shock.

Back to top.

On April 26, 2019, Abiomed received FDA approval to initiate the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT). The pivotal trial will build on the promising results of the successful STEMI DTU safety and feasibility RCT, which met its goal by demonstrating it is safe and feasible to conduct a study of 30 minutes of left ventricle unloading prior to reperfusion after a STEMI heart attack.

The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI and are not in cardiogenic shock. Patients will be randomized 1:1 to either 30 minutes of unloading with Impella CP® prior to reperfusion, or the standard of care – immediate reperfusion. STEMI DTU is currently enrolling.

Impella® heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.

Back to top.

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. 

Back to top.