Ongoing and Upcoming Trials
Learn More About Our Clinical Research
Abiomed is committed to clinical research. Seven completed FDA studies and five post-market approval studies validate Impella® heart pumps as safe and effective for cardiogenic shock, high-risk PCI and right heart failure. Additionally, Abiomed has a number of planned and ongoing studies and randomized controlled trials.
PROTECT IV Randomized Controlled Trial
Ongoing trial to compare complete revascularization PCI with Impella CP® 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® 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.
Impella CP Clinical Evidence Pathway to Class I Recommendation for High-Risk PCI
Learn More About PROTECT IV
Impella CP Clinical Evidence Pathway to Class I Recommendation for AMI Cardiogenic Shock
ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial
A randomized trial of patients undergoing treatment for STEMI who are not in cardiogenic shock to either 30 minutes of left ventricle unloading with Impella CP® prior to reperfusion or immediate reperfusion.
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.
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STEMI-DTU RCT and the Disruptive Concept of Delayed Reperfusion
Navin Kapur, MD, discusses the latest science underlying reperfusion and unloading and how it led to the STEMI-DTU pilot and pivotal trials.
Learn More About STEMI DTU
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
Ongoing trial evaluating the safety and effectiveness in peri-operative use of Impella 5.5® with SmartAssist® in high-risk cardiac surgery patients.
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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References
- Udesen, N. J., et al. (2019). American Heart Journal, 214, 60–68.
NPS-1555