Impella-Supported PCI for Coronary Heart Disease

(PROTECT IV Trial)

Not currently recruiting at 115 trial locations

Overseen By Adam Thompson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Anticoagulants

Disqualifiers: Cardiogenic shock, Severe aortic stenosis, Dialysis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a device called the Impella during certain heart procedures can improve symptoms and heart health in individuals with weakened heart function. The trial will compare this new approach to the usual care for those undergoing high-risk heart procedures. It seeks participants who have experienced specific heart issues, such as a heart attack, and continue to have heart problems. Individuals needing a complex heart procedure may find this trial suitable. As an unphased trial, it provides a unique opportunity to contribute to innovative heart treatment research.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on a chronic oral anticoagulant, it must be safely stopped for at least 72 hours before and after the procedure if it's a vitamin K antagonist, or for at least 48 hours if it's a direct acting oral anticoagulant.

What prior data suggests that the Impella device is safe for use during high-risk PCI?

Research has shown that the Impella heart pump is generally safe for use during high-risk heart procedures. The FDA has approved it, confirming its safety and effectiveness for these procedures.

One study found that using the Impella during high-risk heart procedures was safe for patients with weak heart function, reporting a death rate from any cause of 6.1% to 13.9%. While this indicates some risk, it is considered acceptable given the seriousness of heart conditions.

Another study demonstrated that the Impella heart pump improved survival rates compared to not using it in certain heart emergencies. This suggests that it is not only safe but can also save lives in critical situations.

Overall, the Impella device is well-tolerated, and its benefits outweigh the risks for high-risk patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Impella-Supported PCI because it offers a novel approach to treating coronary heart disease compared to standard procedures like regular PCI with or without an intra-aortic balloon pump. The Impella device acts as a mini heart pump, temporarily supporting the heart's function during high-risk procedures. This method can help maintain stable blood flow and reduce the heart's workload, potentially improving patient outcomes and safety during complex interventions. This innovative mechanism could be a game-changer in managing patients with severe coronary artery disease.

What evidence suggests that the Impella®-Supported PCI is effective for coronary heart disease?

In this trial, participants in the Impella Arm will receive Impella-supported PCI during high-risk heart procedures to open clogged arteries. Studies have shown that the Impella device is highly successful for patients with weak heart function. One study found that 99.1% of patients had successful procedures with Impella assistance. Another study noted an increase in Impella use over time in high-risk cases, indicating its growing acceptance. A review showed that, after six months, the death rate for patients who underwent Impella-supported procedures was 13.4%. These findings suggest that Impella can be a valuable tool in improving outcomes for patients with coronary heart disease undergoing high-risk procedures. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults aged 18-90 with complex coronary artery disease, reduced left ventricular function (LVEF ≤40% or ≤30% in specific cases), and planned high-risk PCI. Candidates must not have life-threatening non-cardiac conditions, recent severe heart attacks, cardiogenic shock, pregnancy, or other serious medical issues that could affect participation.

Inclusion Criteria

I had a severe heart attack between 1 to 30 days ago and my heart's pumping ability is very weak.

I have a specific type of heart blockage and plan to have surgery on it and two other areas.

I have severe blockages in all three main heart arteries and plan to have stent placement in at least two.

Exclusion Criteria

I do not have severe heart, blood, or vascular conditions that would exclude me.

Pregnant or child-bearing potential unless negative pregnancy test within 1 week

I had a severe heart attack within the last 24 hours or have complications from a heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-risk PCI with or without the Impella device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Impella®-Supported PCI

Trial Overview

The trial is testing whether using the Impella® devices during high-risk percutaneous coronary intervention (PCI) improves symptoms and heart function compared to standard care with an intra-aortic balloon pump in patients with significant heart vessel blockage and weakened heart pumping ability.

How Is the Trial Designed?

Group I: Impella Arm Experimental Treatment 1 Intervention

Impella CP® or Impella 2.5 placement prior to high-risk PCI

Group II: Control Arm Active Control 1 Intervention

Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).

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

Published Research Related to This Trial

The Impella CP® device provides effective short-term circulatory support during high-risk percutaneous coronary interventions (PCI) in patients with severely depressed left ventricular function, helping to maintain hemodynamic stability.

In two case reports, the use of the Impella CP® device during PCI was associated with a reduction in complications, demonstrating its potential as a safe option for patients with complex coronary lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Impella in high-risk percutaneous coronary intervention. Moura-Ferreira, S., Ladeiras-Lopes, R., MBala, D., et al.[2021]

The Impella LP 2.5 device was safely used in three patients with severely compromised left ventricular function during elective percutaneous coronary intervention (PCI), showing no acute device-related adverse events and improving mean blood pressure without increasing aortic valve regurgitation.

While the procedure was uncomplicated, two patients required additional pharmacologic support, and one patient unfortunately passed away a month later due to worsening heart failure, indicating the need for larger studies to better assess the efficacy of this device in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with the Impella Recover LP 2.5 micro-axial pump in patients undergoing high-risk coronary angioplasty. Thomopoulou, S., Manginas, A., Cokkinos, DV.[2018]

In a study of 48 high-risk patients with severe coronary artery disease and left ventricle dysfunction, Impella-supported percutaneous coronary interventions (PCIs) led to significant improvements in heart function, with LVEF increasing from 30% to 35% after 6 months.

The reduction in ischemic myocardium burden was substantial, as indicated by a decrease in the British Cardiovascular Intervention Society Jeopardy score, and improvements in wall motion score index were specifically linked to the revascularized heart segments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Impella protected-percutaneous coronary intervention on left ventricle function recovery of patients with extensive coronary disease and poor left ventricular function. Romagnoli, E., Burzotta, F., Cerracchio, E., et al.[2023]

In a study involving 5 high-risk patients with severe coronary artery disease, the use of the Impella mechanical circulatory support device during percutaneous coronary intervention (PCI) was successful, with no complications and all patients remaining alive and well at 30 days post-procedure.

The Impella device effectively unloads the heart, improves blood flow, and reduces oxygen demand, suggesting that its use in high-risk PCI can enhance patient outcomes even in non-surgical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Risk "Protected" Percutaneous Coronary Intervention with Mechanical Circulatory Support in a Non-Surgical Center - An Early Asian Experience. Li, KFC., Ho, HH., Jafary, FH., et al.[2020]

The use of the Impella 2.5 for partial circulatory support during high-risk percutaneous coronary interventions (PCI) in 60 patients showed a high angiographic success rate of 96%, indicating its efficacy in complex cases.

Despite the high-risk profile of patients, including severe heart conditions, the procedure demonstrated safety with only one procedural death and a 30-day mortality rate of 5%, while no major complications like myocardial infarction or stroke occurred.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Impella 2.5 for prophylactic circulatory support during elective high-risk percutaneous coronary intervention. Alasnag, MA., Gardi, DO., Elder, M., et al.[2016]

In a study of 37 patients with reduced left-ventricular ejection fraction undergoing elective Impella-protected percutaneous coronary intervention, significant drops in blood pressure were observed, but all patients maintained systolic blood pressure above 78 mm Hg, ensuring vital organ perfusion.

Critical drops in blood pressure occurred in 10.8% of patients, particularly in those with higher jeopardy scores indicating more severe coronary artery disease, suggesting that careful monitoring is essential in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamics and its predictors during Impella-protected PCI in high risk patients with reduced ejection fraction. Russo, G., Burzotta, F., D'Amario, D., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12221328/

Short- and long-term outcomes of Impella-protected, high ...

A total of 115 patients with low EF received Impella CP support during HR-PCI. The success rate of Impella supported HR-PCI was high (99.1%) with an average ...

2.

heartrecovery.com

heartrecovery.com/en-us/education/education-library/samin-sharma-outcomes-of-impella-supported-high-risk-pci

Samin Sharma: Outcomes of Impella-supported High Risk ...

Dr. Sharma explains that Impella use steadily increased from about 1% of patients to 3-4% of high-risk PCI cases by the end of the study period.

3.

ajconline.org

ajconline.org/article/S0002-9149(25)00556-9/fulltext

Systematic Review and Meta-analysis of Short-Term ...

This is the first meta-analysis to specifically quantify 6-month outcomes in high-risk patients undergoing Impella-supported PCI, reporting a 13.4% mortality ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04763200

Study Details | NCT04763200 | Impella®-Supported PCI in ...

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5358206/

The Duration of Impella 2.5 Circulatory Support and Length ...

Our study suggests that there is a positive correlation between the duration of Impella 2.5 circulatory support and hospital stay and/or CCU days.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9026144/

A Review of the Impella Devices - PMC - PubMed Central

Impella heart pumps (Abiomed) are intravascular microaxial blood pumps that provide temporary MCS during HRPCI or in the treatment of cardiogenic shock.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0914508723002708

Impella – Current issues and future expectations for the ...

Worldwide, Impella is also used for circulatory support during high-risk percutaneous coronary intervention (HRPCI) and ventricular tachycardia (VT) ablation.

8.

abiomed.com

abiomed.com/en-us/products-and-services/impella/impella-cp-with-smartassist

Impella CP® with SmartAssist

The Impella CP with SmartAssist heart pump is designated as safe and effective by the FDA for use during high-risk PCI procedures and for patients in ...

9.

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.

10.

journals.viamedica.pl

journals.viamedica.pl/cardiology_journal/article/view/103336

and long-term outcomes of Impella-protected, high-risk ...

High-risk PCI with Impella CP periprocedural support was safe and effective in patients with low EF (≤ 30%). The all-cause mortality rate (6.1% and 13.9%, ...