Impella ECP Device for High-Risk Heart Procedures

(ECP EFS Trial)

Recruiting at 5 trial locations

Overseen By Viktoria Bulkley, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Heparin, Aspirin

Disqualifiers: Aortic valve disease, Stroke, Dialysis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known contraindication (reason not to use) to heparin, contrast media, or study-required medications like aspirin, you may not be eligible to participate.

What data supports the effectiveness of the Impella ECP treatment for high-risk heart procedures?

Research shows that similar Impella devices, like the Impella CP, provide strong heart support and fewer complications compared to other devices in patients with heart issues, such as cardiogenic shock. This suggests that the Impella ECP might also be effective in supporting the heart during high-risk procedures. ^{1 2 3 4 5}

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

The Impella device has been associated with serious complications such as bleeding, issues with device placement or removal, and vascular problems. There is also a high rate of in-hospital mortality reported, emphasizing the need for more high-quality studies to better understand its safety. ^{3 6 7 8 9}

How is the Impella ECP treatment different from other treatments for high-risk heart procedures?

The Impella ECP is unique because it is a miniaturized mechanical pump that provides temporary support to the heart during high-risk procedures by drawing blood from the left ventricle and expelling it into the aorta, offering greater hemodynamic support with fewer complications compared to other devices like intra-aortic balloon pumps and VA-ECMO. ^{1 2 3 10 11}

Research Team

Amir Kaki, MD

Principal Investigator

Ascension St. John Hospital

Chuck Simonton, MD

Principal Investigator

Abiomed Inc.

Seth Bilazarian, MD

Principal Investigator

Abiomed Inc.

Eligibility Criteria

This trial is for adults aged 18-90 scheduled for a high-risk heart procedure (percutaneous coronary intervention) with hemodynamic support. Participants must consent and not have conditions like previous valve replacements, severe vessel disease, or recent COVID-19 symptoms. They can't join if they're on dialysis, pregnant, in shock, part of another study's active phase, belong to vulnerable populations or have bleeding disorders.

Inclusion Criteria

Age ≥ 18 years and ≤ 90 years

Subject has signed the informed consent

Scheduled for an elective or urgent high risk percutaneous coronary intervention with hemodynamic support

Exclusion Criteria

You have a known condition affecting the blood vessels in your aorta or have experienced a tear in your aorta.

Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin)

Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo high-risk percutaneous coronary intervention with the Impella ECP device providing hemodynamic support

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

30 days

1 visit (in-person), additional follow-up calls

Treatment Details

Interventions

• Impella ECP

Trial Overview The Impella ECP Early Feasibility Study is testing the safety of the Impella ECP device in patients undergoing elective high-risk heart procedures. It's a single-group study where all participants receive the same treatment to see how well it works and what risks are involved.

Participant Groups

Group I: Subjects receiving the Impella ECP Experimental Treatment 1 Intervention

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

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

2. Japan pubmed.ncbi.nlm.nih.gov

Use of Impella CP Device in Off-Pump Coronary Artery Bypass Graft Surgery. [2021]

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

Budget Impact Analysis of Impella CP&#174; Utilization in the Management of Cardiogenic Shock in France: A Health Economic Analysis. [2022]

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

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

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

Percutaneous coronary intervention with Impella support with and without intra-aortic balloon in cardiogenic shock patients. [2023]

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

Short term outcomes of Impella circulatory support for high-risk percutaneous coronary intervention a systematic review and meta-analysis. [2022]

7. 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]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of Impella and intra-aortic balloon pump in high-risk percutaneous coronary intervention: vascular complications and incidence of bleeding. [2022]

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

Analysis of Bicarbonate-Based Purge Solution in Patients With Cardiogenic Shock Supported Via Impella Ventricular Assist Device. [2023]

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

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