Impella ECP Device for High-Risk Heart Procedures

(ECP EFS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of the Impella ECP device, which supports the heart during high-risk procedures to open blocked blood vessels. It seeks participants needing elective or urgent procedures to improve heart blood flow. Ideal candidates are those undergoing planned high-risk heart procedures who require additional support. The trial aims to assess the device's safety and effectiveness in these situations. As an unphased trial, it offers patients the chance to contribute to innovative heart care solutions.

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 prior data suggests that the Impella ECP device is safe for high-risk heart procedures?

Research has shown that the Impella ECP device is safe for use in high-risk heart procedures. One study found that using the Impella ECP during these procedures was safe and linked to fewer deaths shortly after the procedure.

Another study confirmed the device's safety and effectiveness, noting its successful use in most cases. Most doctors in the study used a specific method to close the access site, indicating their trust in the device's safety.

While some studies on other Impella devices have shown a higher death rate over time, these results do not apply to the Impella ECP device used in this trial. Overall, current research supports that the Impella ECP is generally well-tolerated during high-risk heart procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Impella ECP device is unique because it offers a new way to support the heart during high-risk procedures. Traditional options like medications or other mechanical support devices can be more invasive or less efficient. The Impella ECP is a minimally invasive heart pump that assists with blood circulation, reducing the strain on the heart during complex surgeries. Researchers are excited because it has the potential to improve patient outcomes by providing targeted support with fewer complications, making it a promising advancement in cardiac care.

What evidence suggests that the Impella ECP device is effective for high-risk heart procedures?

Research shows that the Impella ECP device, which participants in this trial will receive, performs well in high-risk heart procedures. Studies have found that it lowers the number of deaths shortly after these procedures. The device successfully crossed the aortic valve, an important heart valve, in all of over 500 cases, which is crucial for heart support. It has also been used safely for patients needing surgery after severe heart problems. These findings suggest that the Impella ECP can provide dependable support during complex heart procedures. ^{1 2 4 6 7}

Who Is on the Research Team?

Amir Kaki, MD

Principal Investigator

Ascension St. John Hospital

Seth Bilazarian, MD

Principal Investigator

Abiomed Inc.

Navin Kapur, MD

Principal Investigator

Abiomed Inc.

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. abiomed.com abiomed.com/en-us/about-us/news-and-media/press-releases/impella-ecp-pivotal-study-demonstrates-safety-efficacy-for-use-in-high-risk-pci

Impella ECP Pivotal Study Demonstrates Safety, Efficacy ... The study demonstrated Impella ECP's safety and efficacy for use in high-risk PCI. Operators chose 8Fr Angio-Seal as the first-closure method in 70% of the ...

2. cardiovascularbusiness.com cardiovascularbusiness.com/topics/clinical/interventional-cardiology/impella-heart-pump-provides-value-during-high-risk-pci-meta-analysis-confirms

Impella heart pump provides value during high-risk PCI ... Using an Impella heart pump during high-risk PCI was linked to a reduced short-term mortality rate and an acceptable safety profile.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297506/

Impella support as a bridge to heart surgery in patients with ... Impella is an effective tool for bridging patients with cardiogenic shock to surgery. This strategy may improve surgical outcomes in patients with cardiogenic ...

4. heartrecovery.com heartrecovery.com/en-us/education/education-library/impella-ecp-pivotal-study-first-results

[Impella ECP™ Pivotal Study: First Results] - HeartRecovery “It's had a 100% success rate in crossing the aortic valve in over 500 cases,” Dr. Kaki emphasizes, with the average time required to cross the ...

5. prnewswire.com prnewswire.com/news-releases/impella-ecp-pivotal-study-demonstrates-safety-efficacy-for-use-in-high-risk-pci-302288506.html

Impella ECP Pivotal Study Demonstrates Safety, Efficacy ... The study demonstrated Impella ECP's safety and efficacy for use in high-risk PCI. Operators chose 8Fr Angio-Seal as the first-closure method in 70% of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10269385/

Outcomes of surgical Impella placement in acute ... One-year survival was 54%. Neither etiology of heart failure nor device strategy was associated with 30-day or 1-year survival. On multivariable ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0914508723002708

Impella – Current issues and future expectations for the ... The postoperative 30-day mortality rate was 40 % [45]. At our institution, seven patients with cardiogenic shock requiring radical surgery underwent Impella ...