RecruitingNAINTERVENTIONAL

Corheart 6 LVAS Study

This study is investigating a new device called the Corheart 6 LVAS, which is a type of heart pump designed for people with severe long-term heart failure that hasn't responded to other treatments. The main goal is to find out if this pump is safe and works well for patients in Europe, specifically looking at their health 6 months after the device is put in. Researchers also want to understand its long-term safety and how well it continues to help over a longer period. This research is important for improving treatment options for those living with advanced heart failure.

At a glance

Status

Recruiting

Phase

Sponsor

Shenzhen Core Medical Technology CO.,LTD.

Enrolment target

Start

14 May 2024

Estimated completion

30 Jun 2031

Refractory Heart Failure

What is this study about?

Imagine your heart is a pump, and in heart failure, it's not pumping blood as strongly as it should. If you have what doctors call 'refractory heart failure,' it means your heart is struggling a lot even with the best medicines and treatments available. This study is exploring a new device called the Corheart 6 Left Ventricular Assist System (LVAS). It’s a small mechanical pump that helps your heart by taking over some of its work, making sure your body gets enough blood and oxygen.

The main purpose of this study is to see how well this Corheart 6 LVAS works and if it's safe for people in Europe who have very severe heart failure. Doctors will carefully monitor people who receive this device for at least 6 months after it’s put in to check their health and see if their symptoms improve. They'll also be looking at how well the device works over a longer time.

Taking part in a study like this is a chance to potentially try a new treatment when other options haven't been enough. It also helps doctors and scientists learn more about heart failure and how to treat it, which can help many other people in the future. Remember, it's a research study, and while the aim is to help, there are always things to consider, which your doctor can discuss with you.

Key takeaways

This study explores a new heart pump for very severe heart failure.
It aims to see if the device is safe and effective for European patients.
Participation involves surgery and regular health check-ups.
It's for people whose heart failure hasn't improved with other treatments.
You can discuss with your doctor if this study might be right for you.

Who may be eligible?

To join this study, you would generally need to be between 18 and 75 years old.

You would also need to have very severe heart failure (what doctors call NYHA Class IV) where your heart doesn't pump blood very well, even with the best available medicines. This means your heart has a very low 'ejection fraction' (LVEF less than 25%). On top of this, you might struggle with exercise, have problems with your kidneys or liver because your heart isn't pumping enough, or depend on certain medications (inotropes) to help your heart pump.

However, some things might mean you can't join. For example, if your heart failure could be treated with other standard therapies, or if you have certain blood problems, active infections, or other serious health issues that could make surgery too risky. Also, if you have severe liver damage or certain mental health conditions that might make it hard to follow the study plan, you might not be suitable.

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 between 18 and 75 years old?
Do you have very severe heart failure that hasn't responded to other treatments?
Do you struggle with exercise or have related organ problems?
Are you able to take blood-thinning medications if needed?
Do you not have any active infections or serious liver problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form, which explains everything in detail. You would then undergo surgery to have the Corheart 6 LVAS device implanted. After the surgery, you'll have regular follow-up visits with the study team. These visits will check how you're recovering, how the device is working, and if there are any side effects. They will involve assessments like blood tests, heart checks, and possibly questionnaires about your health and well-being. The study aims to check on your health for at least 6 months after the device is put in, and likely for a longer period to see its ongoing effects. The total duration of your participation will depend on the long-term follow-up plan, which your doctor will explain fully.

Potential risks and benefits

Potential benefits of joining this study could include access to a new treatment option for severe heart failure, which might improve your heart function and quality of life when other treatments haven't worked. However, as with any surgery and new medical device, there are potential risks, including complications from the operation itself, infection, bleeding, or issues with the device. The study team will explain all known risks and closely monitor participants for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Universitätsklinikum Graz
Verified postcode
Graz, Austria· Not yet recruiting
Universitätskliniken der MedUni Wien
Verified postcode
Vienna, Austria· Recruiting
Herz-und Diabeteszentrum Nordrhein-Westfalen
Verified postcode
Bad Oeynhausen, Germany· Recruiting
Deutsches Herzzentrum der Charité
Verified postcode
Berlin, Germany· Recruiting
Klinikum Links der Weser
Verified postcode
Bremen, Germany· Not yet recruiting
Universitätsklinikum Hamburg
Verified postcode
Hamburg, Germany· Recruiting
Universitätsklinikums Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
Herzzentrum Leipzig
Verified postcode
Leipzig, Germany· Recruiting
Universitätsklinikum Würzburg
Verified postcode
Würzburg, Germany· Not yet recruiting
IRCCS Ospedale San Raffaele
Verified postcode
Milan, Italy· Not yet recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Verified postcode
Torino, Italy· Not yet recruiting

Common questions

What is advanced left ventricular heart failure?

It's a very severe form of heart failure where the main pumping chamber of your heart (the left ventricle) is very weak and struggles to pump enough blood to your body.

What does 'LVAS' mean?

LVAS stands for Left Ventricular Assist System. It's a small mechanical pump that helps your heart pump blood.

Is this device surgery?

Yes, having the Corheart 6 LVAS put in requires a surgical operation.

How long will I be in the study?

The study will track your health for at least 6 months after the device is implanted, and potentially for a longer period to understand its long-term effects.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your care.

How to find out more

Xiaoli Shi

shixiaoli@coretechmed.com +86 13418601356 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.