Active not recruitingNAINTERVENTIONAL

IMPACT EU Post-Market Clinical Follow-Up Study

This study is gathering more information on a device called Impella 5.5, which is used in people having major heart surgery. These patients often have a condition where their main heart pump (left ventricle) is weak. The Impella 5.5 is designed to help the heart work better during and after surgery. Researchers want to understand if it's safe to use and how effective it is at helping patients recover, improving their daily lives, and preventing further heart problems after surgery. This is a follow-up study for a device already on the market in Europe, involving up to 123 patients who will be monitored for up to a year.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abiomed Inc.

Enrolment target

123

Start

27 Apr 2023

Estimated completion

08 Aug 2026

Left Ventricular Dysfunction

What is this study about?

Imagine your heart has a main pump, called the left ventricle, which pushes blood out to your body. For some people, this pump can become weak, especially if they need complex heart surgery. This study is looking at a device called Impella 5.5, which is already available, to see how well it works and how safe it is for these patients during and after their operation.

The Impella 5.5 is a small heart pump designed to give your own heart a helping hand, specially when it’s under stress or recovering from surgery. The main goal is to check if this device can reduce problems after surgery, help your body recover, and improve how you feel and your quality of life in the long run. This information helps doctors understand exactly when and how to best use the Impella 5.5 to support patients with weak hearts.

This study will follow up to 123 patients in different hospitals across Europe for up to a year. By carefully collecting information from these patients, doctors can learn more about the best ways to care for people with weak hearts needing surgery, making sure they get the best possible treatment.

Key takeaways

This study is for patients with a weakened heart pump needing specific major heart surgery.
It's looking at the Impella 5.5 device, which helps the heart work.
Researchers want to understand the device's safety and effectiveness for recovery and quality of life.
Participation involves giving consent and attending follow-up visits for up to one year.
The study aims to improve care for high-risk heart surgery patients.

Who may be eligible?

To be able to join this study, you would need to be at least 18 years old and be scheduled for a specific type of complex heart surgery, such as a bypass, or surgery on your heart valves. A key part of joining is having a weakened main heart pump (left ventricle) before your surgery, as measured by your doctor.

However, there are reasons you might not be able to join. For example, if you've recently had a serious heart emergency, if you're already using other mechanical heart support devices, or if you have certain other heart conditions, you likely wouldn't be suitable. Also, if your planned surgery involves a full stop of your blood circulation, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for heart bypass surgery or heart valve surgery?
Has your doctor told you that you have a weak main heart pump (left ventricle)?
Are you able and willing to attend follow-up visits for up to a year?
Have you *not* had a recent heart emergency or are you *not* on other mechanical heart support devices?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first need to give your permission by signing a consent form. You will be closely monitored during and after your heart surgery, where the Impella 5.5 device would be used. After your surgery, you would have several follow-up visits with the study team. These visits will check how you are recovering and how the device has helped. You would need to be willing and able to attend all these appointments and complete any tests required over the study period, which will last for up to one year.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as contributing valuable information that could help future patients with similar heart conditions. While the Impella 5.5 is an established device, there are always potential risks with any medical procedure or device, and the study will carefully monitor these. You will be fully informed of all known and potential risks before deciding to participate. Remember, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (13)

IKEM Prague
Verified postcode
Prague, Czechia
Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
Verified postcode
Heidelberg, Germany
RWTH Uniklinik Aachen - Klinik für Herzchirurgie
Verified postcode
Aachen, Germany
Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie
Verified postcode
Düsseldorf, Germany
Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin
Verified postcode
Essen, Germany
Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie
Verified postcode
Mainz, Germany
Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie
Verified postcode
Halle, Germany
UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie
Verified postcode
Kiel, Germany
Deutsches Herzzentrum der Charité
Verified postcode
Berlin, Germany
Universitätsklinikum Giessen
Verified postcode
Giessen, Germany
Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
Verified postcode
Hamburg, Germany
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany

Common questions

What is the Impella 5.5?

It's a small pump that helps your heart push blood around your body, especially during and after complex heart surgery.

Why is this study being done?

Doctors want to gather more information on how safe and effective the Impella 5.5 is for patients with weak hearts undergoing major surgery.

Who can take part in this study?

Adults aged 18 or over who have a weakened heart pump and are having specific types of major heart surgery.

How long will I be in the study if I join?

You would be followed by the study team for up to one year after your surgery.

Will I get special care if I join?

You will receive regular medical care and be closely monitored by the study team as part of taking part in the study.