Active not recruitingNAINTERVENTIONAL

Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function

This study is designed for people who have serious blockages in their heart arteries and weakened heart muscles. These patients are considered high-risk for a common procedure called PCI (percutaneous coronary intervention), which opens up blocked blood vessels. The study wants to find out if using a small heart pump called Impella (specifically Impella CP or Impella 2.5) during this PCI procedure helps patients recover better. Researchers will compare patients who receive the Impella pump to those who get the usual care. They will check if using Impella can improve symptoms, heart function, and overall health over three years, looking at serious events like heart attacks, strokes, or further hospital stays.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abiomed Inc.

Enrolment target

1,252

Start

13 Apr 2021

Estimated completion

01 Oct 2027

Left Ventricular Dysfunction Coronary Artery Disease

What is this study about?

If you have coronary artery disease, it means the blood vessels supplying your heart are narrowed or blocked. This can lead to serious problems like a heart attack. If your heart muscles are also weakened (this is what 'reduced left ventricular function' means), you might find it harder to do everyday activities and could be at higher risk during certain heart procedures. One common procedure to open up blocked arteries is called PCI, or percutaneous coronary intervention, sometimes known as angioplasty and stenting.

This research project is looking at people who need PCI but are considered to be at high risk because of their complex coronary artery disease and weakened heart muscle. The study is investigating whether using a small device called Impella during the PCI procedure can offer better results compared to the standard way of doing things. The Impella device is a tiny pump that helps your heart by temporarily supporting blood flow during the procedure.

The main goal is to see if using the Impella pump leads to fewer serious problems over three years, such as fewer deaths, strokes, heart attacks, or repeat procedures. Researchers also want to see if it helps improve your symptoms, how well your heart works, and your general health in the long run. By comparing those who receive Impella with those who get standard care, the study hopes to find the best way to help patients like you.

Key takeaways

This study focuses on high-risk patients needing heart artery procedures.
It compares a small heart pump (Impella) with standard care during PCI.
The goal is to see if Impella improves long-term heart health and reduces complications.
Participants must have complex heart disease and weakened heart muscles.
Your health will be monitored for up to three years after the procedure.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for adults aged between 18 and 90 years old. To be considered, you must have serious blockages in your heart arteries that your doctors believe can best be treated with a PCI procedure. A team of heart specialists, including a heart surgeon and special cardiologist, will need to agree that PCI is the right treatment for you.

You also need to have weakened heart muscle. This is measured by something called your 'left ventricular ejection fraction' (LVEF). If you have certain heart conditions (like unstable angina or a specific type of heart attack called NSTEMI), your LVEF needs to be 40% or less. If you've recently had a more serious type of heart attack (STEMI) that happened at least 24 hours ago but less than 30 days ago, your LVEF needs to be 30% or less.

Finally, the PCI procedure you need must be quite complex – for example, it might involve multiple blocked vessels or other challenging features that your doctors will assess. Your cardiologist will check all these specifics using your medical records and tests like ultrasound scans of your heart. It’s important that your heart function is carefully measured and confirmed by the study. If you meet these main criteria, you might be eligible to take part.

Quick self-check

Are you between 18 and 90 years old?
Has your heart doctor recommended a PCI procedure for complex blockages?
Do you have weakened heart muscles (your doctor can tell you your LVEF score)?
Have your heart specialists agreed that PCI is the best treatment option for you?
Have you recently experienced specific heart conditions mentioned by your doctor, e.g., NSTEMI or STEMI?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first undergo a screening process to ensure you meet all the necessary health requirements. If eligible, you will be assigned to either receive the Impella heart pump during your PCI procedure or to receive standard care, which may include another type of support device if your doctor deems it necessary. You will have your PCI procedure as planned.

After your procedure, you will have regular check-ups. These check-ups will include physical examinations, blood tests, and scans of your heart to see how well it's recovering and functioning. The study will monitor your health for a long period – up to three years after your PCI procedure. This allows researchers to get a comprehensive understanding of the long-term effects of the interventions. You'll have follow-up appointments at specific times, for example, at 30 days, 6 months, 1 year, 2 years, and 3 years post-procedure. The total duration of your participation will be three years.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that if the Impella device proves effective, it could lead to better outcomes for your heart condition, potentially reducing serious complications and improving your quality of life. However, there's no guarantee that you will personally benefit. Potential risks include those associated with any heart procedure or medical device, such as bleeding, infection, or other complications. Your doctors will explain all known risks to you. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (99)

University of Alabama
Birmingham, United States
St. Joseph's Medical Center - Phoenix
Phoenix, United States
Northwest Medical Center Tucson
Tucson, United States
Arkansas Cardiology
Little Rock, United States
Adventist Health Glendale
Glendale, United States
St. Joseph Hospital - Orange
Orange, United States
Loma Linda University Health
San Bernardino, United States
UCSD Medical Center
San Diego, United States
Colorado Heart and Vascular
Lakewood, United States
The Cardiac & Vascular Institute
Gainesville, United States
University of Florida Health - Gainesville
Gainesville, United States
UF Health Jacksonville
Jacksonville, United States

+87 more sites — see the official record for the full list.

Common questions

What is the Impella device?

The Impella is a very small pump inserted into your heart to help it pump blood around your body during a procedure, giving your heart a rest.

What does 'PCI' mean?

PCI stands for Percutaneous Coronary Intervention. It's a common heart procedure where doctors use a balloon and often a small tube (stent) to open up blocked heart arteries.

What is 'reduced left ventricular function'?

This means your heart's main pumping chamber (the left ventricle) isn't squeezing blood as strongly as it should, making your heart less efficient.

Will I know if I'm getting the Impella device?

In this study, some patients will receive the Impella and others the standard care. Your doctors will know which treatment you are getting and will discuss this with you.

How long will I be followed up in this study?

You will be followed up for three years after your heart procedure to track your health and recovery over time.