PROTECT IV Randomized Controlled Trial
RECOVER IV Randomized Controlled Trial
STEMI DTU Randomized Controlled Trial
National Cardiogenic Shock Initiative (NCSI) Study
DanGer Shock Randomized Controlled Trial
FDA Post-Approval Studies
The intent of the PROTECT IV Randomized Controlled Trial (RCT) is to leverage and validate the best practices learned from the cVAD Study, IQ Database and real-world data collected since the completion of the PROTECT II Randomized Controlled Trial.
The prospective, two-arm, RCT will compare complete revascularization PCI with Impella to complete revascularization PCI without any planned hemodynamic support. The study is in the trial preparation phase. The first patient is expected to enroll in 2021.
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.
The RECOVER IV Randomized Controlled Trial (RCT) will assess whether Impella pre-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 circulatory support.
The trial design is being developed and will leverage the STEMI DTU trial network. Inclusion/exclusion criteria for the RECOVER IV RCT will be similar to the investigator initiated National Cardiogenic Shock Initiative Study. It is expected the first patient will enroll in 2021.
As shown in the chart below, RECOVER IV is part of the Impella clinical evidence pathway to a Class I clinical guideline recommendation for cardiogenic shock.
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.
National Cardiogenic Shock Initiative (NCSI) Study is an independent, physician-led, national, multicenter initiative aimed at improving mortality in patients with AMI cardiogenic shock (AMICS).1 Based on the consistent finding of good survival outcomes with early hemodynamic support with Impella therapy from the IQ database and cVAD study, a best practices algorithm for the treatment of patients with AMICS was established. The NCSI algorithm includes identifying shock early, use of Impella therapy before PCI, reducing the use of inotropes, and the use of invasive hemodynamic monitoring to aid in escalation and weaning.
As of September 2019, 250 patients with AMI cardiogenic shock from 49 NCSI sites treated using Impella best practices have demonstrated 72% survival with 98% native heart recovery at discharge.2
- Basir, M. B., et al. (2019). Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheterization and Cardiovascular Interventions, 93(7), 1173-1183. doi: 10.1002/ccd.28307
- O'Neill, W. W., M.D. (2019). Acute Cardiogenic Shock: The Number One Unresolved Challenge in Cardiovascular Disease. Lecture presented at TCT 2019, San Francisco.
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 100 patients have been enrolled.1
- Udesen, N. J., et al. (2019). Rationale and design of DanGer shock: Danish-German cardiogenic shock trial. American Heart Journal, 214, 60–68. doi: 10.1016/j.ahj.2019.04.019
A prospective, multicenter, single-arm post-approval study (PAS) of use of the percutaneous Impella devices in elective or urgent high-risk PCI. The interim results of this study were presented at TCT in 2019. Anticipated completion is during 2020.
A prospective, multicenter, single-arm post-approval study of patients supported with Impella devices for the indication of AMI cardiogenic shock (AMICS) and enrolled in the cVAD registry.
A prospective, multicenter, single-arm post-approval study of patients who suffered cardiogenic shock after open heart surgery and received an Impella device.
This prospective/retrospective, multi-center, single-arm post-approval study is monitoring safety and efficacy trends of patients 18 years or older treated with Impella RP for right heart failure.
This prospective/retrospective, multi-center, single-arm post-approval study is monitoring safety and efficacy trends of patients aged 15-17 years old treated with Impella RP for right heart failure.
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/