Ongoing and Upcoming Trials
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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 high-risk PCI, cardiogenic shock 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 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.
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.
Impella Clinical Evidence Pathway to Class I Recommendation for High-Risk PCI
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First Patient Enrolled in PROTECT IV Randomized Controlled Trial of Impella
The PROTECT IV RCT will leverage advancements in technology and best practices learned since the completion of the PROTECT II RCT and the FDA pre-market approval for Impella heart pumps for high-risk PCI.
PROTECT IV and MCS for High-Risk PCI
Gregg Stone, MD, principal investigator for the PROTECT IV randomized controlled trial, discusses data supporting the use of mechanical circulatory support for high-risk PCI.
PROTECT IV Study Design
Dr. Stone introduces the study by describing the complex and high-risk PCI (CHIP) patient population and asking the question, “By using mechanical circulatory support, can we improve their short-term or long-term outcomes?”
RECOVER IV Randomized Controlled Trial
Upcoming trial to assess whether Impella support, used pre-PCI, is superior to PCI without Impella in patients with AMI cardiogenic shock.
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.
ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial
Ongoing 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.
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.
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Key Points of the STEMI-DTU Pilot Trial
The STEMI DTU pilot trial demonstrated for the first time that LV unloading using the Impella CP® heart pump with a 30-minute delay before reperfusion is safe and feasible.
What is the STEMI DTU Pivotal Trial?
The trial will test the hypothesis that unloading the left ventricle for 30 minutes prior to reperfusion will reduce myocardial damage from a heart attack and lead to a reduction in future heart failure-related events.
DanGer Shock Randomized Controlled Trial
Ongoing trial assessing primary outcome of death from all causes at 6 months with Impella CP compared to standard of care.
This ongoing, open-label randomized controlled trial (RCT) was initiated in patients with AMICS in Denmark. In 2018, it was expanded to enroll patients from Germany and renamed the DanGer Shock Trial. A total of 360 cardiogenic shock patients are planned to be enrolled to assess the primary outcome of death from all causes at 6 months with Impella CP compared to standard care. Since study initiation in December 2012, more than 150 patients have been enrolled.1
- Udesen, N. J., et al. (2019). American Heart Journal, 214, 60–68.