Impella CP® for Heart Attack and Cardiogenic Shock

(RECOVER IV Trial)

No longer recruiting at 14 trial locations

Overseen By Sameera Dasari, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Disqualifiers: End-stage renal disease, Severe aortic stenosis, Prior stroke, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Impella CP® device can improve survival and recovery in individuals experiencing certain heart attacks with serious heart failure. Specifically, it focuses on STEMI heart attacks, where the heart struggles to pump enough blood, leading to symptoms like low blood pressure and cold extremities. Participants will receive either the Impella device or standard care to determine which is more effective. Individuals who have experienced a heart attack with severe heart failure symptoms and plan to undergo an emergency procedure to open blocked heart arteries may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future heart attack treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Impella CP® device is safe for use in patients with STEMI-Cardiogenic Shock?

Research has shown that the Impella CP® heart pump is generally well-tolerated by patients with heart problems. One study found that patients using the Impella CP had a 12.7% higher chance of survival compared to those who did not use it during cardiogenic shock, a condition where the heart suddenly can't pump enough blood. Another study indicated that patients with the Impella CP lived an average of 600 more days over a 10-year period compared to those without it.

However, some risks exist. In certain cases, patients experienced a sudden drop in kidney function more often when the Impella CP was used with other devices. Despite these risks, evidence suggests that the benefits, such as improved survival, make the Impella CP a promising option for those with serious heart conditions. Patients should always consult their healthcare provider to weigh the benefits and risks for their specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Impella CP® because it offers a unique approach to treating heart attacks complicated by cardiogenic shock. Unlike traditional treatments that rely on medication and supportive care, the Impella CP® provides mechanical hemodynamic support, which helps the heart pump blood more effectively during a critical intervention. This device is inserted through a minimally invasive procedure and can be initiated before a percutaneous coronary intervention (PCI), potentially stabilizing patients more quickly and improving outcomes. This innovative strategy is what sets it apart from the current standard of care and highlights its potential to transform how this severe condition is managed.

What evidence suggests that the Impella CP® is effective for heart attack and cardiogenic shock?

Research has shown that the Impella CP heart pump can improve survival rates for individuals experiencing cardiogenic shock, a severe heart condition often following a heart attack. In this trial, participants in the Treatment Arm will receive hemodynamic support through an Impella-based treatment strategy. One study found that patients using the Impella CP had a 12.7% higher survival rate compared to those receiving standard treatment without it. Another study demonstrated that individuals using the Impella CP lived an average of 600 more days over ten years than those who did not use the device. These findings suggest that the Impella CP may provide significant long-term health benefits for patients with cardiogenic shock. ^{1 2 3 4 6}

Who Is on the Research Team?

Navin Kapur, MD

Principal Investigator

Tufts Medical Center

William O'Neill, MD

Principal Investigator

Henry Ford Health System

Gregg Stone, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

The RECOVER IV Trial is for patients who've had a severe type of heart attack (STEMI) leading to cardiogenic shock within the last 12 hours. They must be planning to undergo an emergency procedure to open blocked arteries (PCI), have low blood pressure despite treatment, and show signs of poor blood flow to organs. Excluded are those with certain medical conditions like prior strokes, severe infections, or life expectancy less than a year.

Inclusion Criteria

Subject is able to and agrees to provide written informed consent. If the subject is unable to be consented because of their extreme illness and a legally authorized representative (LAR) is present, the LAR must agree and provide written informed consent. If the subject is unable to provide consent because of their extreme illness and an LAR is not present, the patient may be randomized under Exception from Informed Consent (EFIC) Guidance

I have specific heart attack signs on an EKG and a confirmed blockage in my heart's arteries.

I am scheduled for an emergency procedure to treat a severe heart attack.

Exclusion Criteria

Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint or any cardiogenic shock trial other than a registry

You are already using certain devices to help your heart function.

You are part of a group that may have difficulty making decisions for themselves, like people with disabilities or those living in nursing homes or homeless shelters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hemodynamic support using an Impella-based treatment strategy initiated prior to PCI

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Impella CP®

Trial Overview This trial tests if starting Impella CP® support before opening blocked arteries in the heart improves survival and recovery compared to standard treatments without Impella. Patients with STEMI-cardiogenic shock will either receive this device-based strategy or continue with usual care methods before their PCI procedure.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Subjects randomized to the Treatment Arm will receive hemodynamic support using an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI).

Group II: Control Arm Active Control 1 Intervention

Subjects randomized to the Control Arm will be treated based on recommendations for cardiogenic shock in the contemporary AHA/ACC/SCAI and ESC Practice Guidelines for STEMI and Heart Failure Management and local standard of care.

Who Is Running the Clinical Trial?

Abiomed Inc.

Lead Sponsor

Trials

47

Recruited

33,900+

Founded

1981

Headquarters

Danvers, United States

Known For

Heart Recovery Technologies

Top Products

Impella heart pumps, AbioCor, Breethe OXY-1 System

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40846118/

Outcomes with Impella CP in Acute Myocardial Infarction ... Impella CP alone was used in 38.3%, CP+ECMO in 23.1%, and CP+≥2 other devices in 20.4%. Acute kidney injury was more common in HF-CS than AMI-CS ...

2. heartrecovery.com heartrecovery.com/en-us/education/education-library/faq-rct-data-impella-cardiogenic-shock

RCT Data for Impella® Heart Pump Use in Cardiogenic ... The Impella CP heart pump improves survival by 12.7% compared to standard treatment without Impella in patients experiencing cardiogenic shock.

3. investor.jnj.com investor.jnj.com/investor-news/news-details/2025/New-Data-from-the-DanGer-Shock-Randomized-Control-Trial-Published-in-The-New-England-Journal-of-Medicine-Confirms-the-Long-Term-Survival-Benefit-of-the-Impella-CP-Heart-Pump/default.aspx

New Data from the DanGer Shock Randomized Control Trial ... When compared to the control arm at 10 years, Impella CP patients gained an average of 600 additional days alive (95% CI: 235 – 966 days)1. The ...

4. academic.oup.com academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaf787/8284788

DanGer shock criteria and outcomes in acute myocardial ... The recent DanGer shock trial demonstrated improved 180-day mortality with Impella compared to conventional care in carefully selected patients ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.043266

Impact of Baseline Cardiogenic Shock Severity on ... Complications and outcomes of Impella treatment in cardiogenic shock patients with and without acute myocardial infarction. J Am Heart Assoc.

6. jhltonline.org jhltonline.org/article/S1053-2498(25)02209-0/abstract

Outcomes with Impella CP in acute myocardial infarction vs ... Survival to discharge was 53.4% and was higher in HF-CS than AMI-CS (59.7% vs 49.8%; p < 0.001). Those with ≥2 other devices had the lowest ...