Impella ECP Device for Heart Procedure Support

Recruiting at 32 trial locations

Overseen By Viktoria Bulkley, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Heparin, Contrast media, Aspirin

Disqualifiers: Aortic valve disease, Stroke, Dialysis, others

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

Compensation: Varies

Number of Visits: 1

Duration: During hospital stay

556 Participants Needed

Trial Summary

What is the purpose of this trial?

The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention. The above applies to Impella ECP Continued Access Protocol

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known allergy to heparin or other study-required medications, you may not be eligible to participate.

What data supports the effectiveness of the Impella ECP treatment for heart procedure support?

Research on similar Impella devices, like the Impella CP and Impella 2.5, shows they provide strong heart support and fewer complications compared to other devices. These findings suggest that the Impella ECP might also be effective in supporting heart procedures. ^{1 2 3 4 5}

Is the Impella ECP device generally safe for use in humans?

The Impella devices, used for heart support, have been associated with serious complications like bleeding, issues with device placement, and vascular problems. There is also a high rate of in-hospital deaths reported, highlighting the need for more research to confirm their safety. ^{2 3 6 7 8}

How is the Impella ECP treatment different from other treatments for heart procedure support?

The Impella ECP is a unique treatment because it is a miniaturized pump that helps the heart by drawing blood from the left ventricle and pushing it into the aorta, providing mechanical support during heart procedures. Unlike other treatments, it is inserted through a small incision and can be used in high-risk heart interventions, offering a less invasive option compared to traditional surgical methods. ^{9 10 11 12 13}

Research Team

Amir Kaki, MD

Principal Investigator

Ascension St. John Hospital

Seth Bilazarian, MD

Principal Investigator

Abiomed Inc.

Chuck Simonton, MD

Principal Investigator

Abiomed Inc.

Eligibility Criteria

Adults aged 18-90 who need high-risk heart procedures (not emergency ones) and are stable enough for it. They must understand the study and agree to participate. People with kidney failure on dialysis, severe valve disease, blood clots in the heart, certain vessel diseases, recent strokes or bleeding in the brain, severe heart failure, or part of vulnerable groups like those with mental disabilities can't join.

Inclusion Criteria

Subject signed the informed consent

My heart condition is stable, and a team of heart specialists has recommended a specific heart procedure.

I am between 18 and 90 years old.

Exclusion Criteria

I have had surgery to replace or repair my aortic valve.

Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures

I am currently experiencing severe heart failure or shock.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo Impella ECP placement and high-risk percutaneous coronary intervention with mechanical circulatory support

During hospital stay

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of MACCE and other safety endpoints

30 days

Treatment Details

Interventions

• Impella ECP

Trial Overview The trial is testing a device called Impella ECP during high-risk procedures to open blocked arteries in the heart. It's looking at how well it prevents major problems like heart attacks or strokes after treatment. Everyone gets the same device; there's no comparison group.

Participant Groups

Group I: Impella ECP Device Experimental Treatment 1 Intervention

Subjects receiving the Impella ECP.

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Ecpella 5.5: An Evolution in the Management of Mechanical Circulatory Support. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Budget Impact Analysis of Impella CP® Utilization in the Management of Cardiogenic Shock in France: A Health Economic Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of left ventricular unloading using a peripheral Impella®-pump in eCPR patients. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Practical Management of ECPELLA. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Benefit of veno-arterial extracorporeal membrane oxygenation combined with Impella (ECpella) therapy in acute coronary syndrome with cardiogenic shock. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Escalation from impella 5.5 to ECPELLA support as a bridge to mitral valve surgery in a patient with degenerative mitral regurgitation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Use of the Impella Device for Acute Coronary Syndrome Complicated by Cardiogenic Shock - Experience From a Single Heart Center With Analysis of Long-term Mortality. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Use of Impella Devices for Acute Cardiogenic Shock in the Perioperative Period of Cardiac Surgery. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Successful Treatment of Left Ventricular Perforation Occurring After Insertion of an Impella Device. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

A case of left ventricular free wall rupture after insertion of an IMPELLA® left ventricular assist device diagnosed by transesophageal echocardiography. [2021]