Ongoing and Upcoming Clinical Trials in Cardiogenic Shock, High Risk PCI and Surgery

Ongoing trial to compare complete revascularization PCI with Impella CP^TM to complete revascularization PCI without any planned hemodynamic support.

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^TM 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.

Ongoing trial evaluating the safety and effectiveness in peri-operative use of Impella 5.5^TM with SmartAssist^TM in high-risk cardiac surgery patients.

Heart recovery at Johnson & Johnson MedTech officially began the IMPACT trial in the United States on September 21, 2023. This feasibility trial is designed to determine the safety and feasibility 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 for future study.

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

US IMPACT results were presented at AATS in May, and publication of the study results are in process.

OASIS-AMICS is a prospective, multi-center, observational study designed to capture real-world clinical data across sites to evaluate safety outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) treated with Impella CP^TM in accordance with approved indications and current standard-of-care best practices.

The study aims to generate clinical evidence on the safety profile of Impella-supported management through the application of best practices in the catheterization laboratory and cardiac intensive care unit (CICU), and to evaluate their impact on patient outcomes in this high-risk population.

The study evaluates a composite in-hospital safety endpoint (major bleeding, acute limb ischemia, and acute kidney injury requiring renal replacement therapy) and key longitudinal outcomes including all-cause mortality, MACCE, and heart failure-related events through 1-year follow-up.

OASIS-AMICS is part of the broader Impella clinical evidence strategy to optimize best practices in AMICS management and reduce variability in care, with the goal of improving safety outcomes and advancing evidence-based treatment approaches.

The INTeGRATE trial is being conducted in the United States and is designed to study utilization and outcomes of Impella 5.5 with aggressive guideline directed medical therapy (GDMT). The trial is designed to study if hemodynamic stabilization and end-organ perfusion by Impella allows for better GDMT optimization, if implementing GDMT while on Impella 5.5 support is safe in stabilized HF-CS patients and does optimization of GDMT with Impella 5.5 support heart recovery.

INTeGRATE is a prospective, single-arm, multi-center on-label trial that enrolled up to 250 patients presenting with HF-Cardiogenic Shock. Primary endpoints include composite of all-cause death, heart replacement (transplant or durable VAD), and HF readmission at 180 days post enrollment. Secondary endpoints include all-cause mortality, CV mortality, CV readmission, worsening HF, GDMT optimization score, GDMT AEs, major device-related AEs, and functional endpoints.