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 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 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 first patient was enrolled in April 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.

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Impella Clinical Evidence Pathway to Class I Recommendation for High-Risk PCI

Graph explaining Impella clinical evidence pathway to Class I recommendation for high-risk PCI

RECOVER IV Randomized Controlled Trial

Upcoming trial to assess whether Impella pre-PCI is superior to PCI without Impella in patients with AMI cardiogenic shock.

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 (NSCI) Study.

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.

 

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Impella Clinical Evidence Pathway to Class I Recommendation for AMI Cardiogenic Shock

Graph explaining Impella clinical evidence pathway to Class I 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.

 

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National Cardiogenic Shock Initiative (NCSI) Study

The NCSI Study seeks to improve mortality in patients with AMI cardiogenic shock using the NCSI algorithm that includes identifying shock early, using Impella therapy before PCI, reducing the use of inotropes, and using invasive hemodynamic monitoring to aid in escalation and weaning.

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.

The final NCSI Study report was presented at SCAI 2021. It included 406 patients with AMI cardiogenic shock from 80 participating sites who were treated using the NCSI protocol, which includes early use of Impella. The study demonstrated 71% survival to discharge with more than 90% native heart recovery.1

 
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Chart showing the historical advancements of cardiogenic shock in published investigator-lead studies

Explore the Latest Data from NCSI

 

Final Results from the NCSI Study Report Demonstrate Benefit of Early Impella Cardiac Unloading

The final results from the NCSI Study demonstrate a 71% survival to discharge with a greater than 90% native heart recovery when best practices are used.

 

Achieving >70% AMI-CS Survival: Insight From National Cardiogenic Shock Initiative

Interventional cardiologist William O'Neill, MD, discusses the application of best practices from the NCSI Study.

 

National Cardiogenic Shock Initiative (NCSI) Study Findings Regarding Right Ventricular Dysfunction

Babar Basir, DO, discusses findings on right heart dysfunction from the NCSI Study.

RESTORE EF

Ongoing study to investigate whether the extent of complete revascularization is associated with the degree of LV improvement. An interim analysis presented at TCT 2020, and detailed in the charts below, found the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at follow-up.

 

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Chart of LVEF Improvement at 90-day follow up
Chart of heart failure and anginal symptom improvement at follow-up

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.2

 
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PROTECT III Post-Approval Study

Ongoing post-market approval (PMA) study of Impella 2.5® and Impella CP demonstrating reduction in MACCE at 90 days with Impella-supported Protected PCI compared to PROTECT II.

A prospective, multicenter, single-arm post-approval study (PAS) of use of Impella devices in high-risk PCI. The interim results were presented at the TCT conference in 2019 and 2020. At TCT 2020, study authors presented an analysis of patients in PROTECT III who would have qualified for PROTECT II, known as “PII-like” patients, and compared them to PROTECT II patients. As detailed in the chart below, PII-like patients in PROTECT III had improved 90-day MACCE rates, compared to PROTECT II patients (15% vs. 21.9%, p=0.035).

 

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Chart of 90-day MACCE: Protect III protect II-like patients versus protect II RCT
 

Contemporary Practices of High-Risk PCI With Percutaneous MCS

Jeffrey W. Moses, MD, presents results from the PROTECT III study which included 1,143 patients undergoing elective non-emergent PCI with the Impella® heart pump from 45 sites.

RECOVER III Post-Approval Study

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 study.

Investigators presented data from RECOVER III at TCT 2020 that found pre-PCI use of Impella for AMI cardiogenic shock is associated with higher rates of survival, particularly in women.

 

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Impella® Post-Cardiotomy Cardiogenic Shock Post-Approval Study

A prospective, multicenter, single-arm post-approval study of patients who suffered cardiogenic shock after open heart surgery and received an Impella device.

 

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Impella RP® Post-Approval Study

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.

Study data presented at TCT 2020 found patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received delayed right-heart support (73% vs. 14%, p<0.001).

 

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Chart of Impella RP cVADD PAS Outcomes

Impella RP® Pediatric Post-Approval Study

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.

 

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References

  1. Basir, B., et al. (2021). SCAI Scientific Sessions.
  2. Udesen, N. J., et al. (2019). American Heart Journal, 214, 60–68. 

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