Not yet recruitingNAINTERVENTIONAL

DuoCor 2 DOMINATE Study

This study is looking at a new device called the DuoCor Ventricular Assist System. It's designed for people with severe heart failure where both the left and right sides of the heart are weak and can't pump enough blood. For these patients, current treatments often aren't enough, and while a heart transplant is an option, donor hearts are very limited. Existing heart support devices don't always work for both sides of the heart, or they can have many complications. The DuoCor system aims to help both sides of the heart pump blood effectively. It's hoped to be easier to fit and cause fewer problems like blood clots or infections. This study will check if the DuoCor system is safe and works well for people with this type of advanced heart failure.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Shenzhen Core Medical Technology CO.,LTD.

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Apr 2029

Advanced Heart Failure

What is this study about?

Imagine your heart as a powerful pump with two main sides, a left and a right, working together to circulate blood throughout your body. In advanced heart failure, one or both of these sides become very weak and can no longer pump enough blood to meet your body's needs. This can be a very serious and life-threatening condition.

While there are many treatments for heart failure, sometimes they aren't enough for the most severe cases. A heart transplant is often considered the best long-term solution, but there aren't nearly enough donor hearts for everyone who needs one. Other devices are available that can help the left side of the heart pump, but they don't always work for people whose right side is also very weak.

This study is about a new device called the DuoCor Ventricular Assist System. It's designed specifically for people whose heart failure affects both the left and right sides of their heart. This device uses two small pumps inserted into the body to help both sides of the heart work at the same time. The goal is to make the surgery less complicated, allow patients to be more mobile, and reduce common problems like blood clots or infections that can happen with other devices. This study will help doctors understand if the DuoCor system is a safe and effective new option for people needing this kind of advanced heart support.

Key takeaways

This study is for a new device called DuoCor.
It helps people with very severe heart failure affecting both sides of their heart.
The device aims to improve blood pumping and quality of life.
It's being tested for safety and how well it works.
Participants will have surgery and regular follow-up appointments.
Potential benefits come with potential surgical and device-related risks.

Who may be eligible?

This study is looking for adults between 18 and 75 years old who have very serious heart failure affecting both the left and right sides of their heart. This means their heart is struggling so much that they might need medications to help it pump, or tests show their heart isn't circulating enough blood.

To be considered, your heart's pumping ability would be significantly reduced on both sides, as shown by various heart measurements and scans. It's important that your heart failure is long-lasting and severe.

However, you wouldn't be able to join if you have certain other conditions, like specific heart muscle diseases, problems with blood clotting, or if you can't take certain blood-thinning medicines. Also, if there are technical reasons that would make the surgery too risky, or if you've been on temporary heart support machines for a long time, you might not be eligible. If you've previously had a permanent heart assist device fitted and refused to change it, that would also exclude you.

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 affecting both sides of your heart?
Is your heart so weak it might need medication to help it pump?
Are you able to take blood-thinning medications?
Have you signed a document saying you understand and agree to the study?
Do you not have certain other serious heart or blood conditions?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve having the DuoCor device surgically implanted. After the surgery, you would have regular hospital visits and check-ups to monitor your health and how the device is working. These appointments would include physical exams, blood tests, and scans of your heart. You would also need to take specific medications, like blood thinners, as prescribed by the study doctors. The study staff will guide you through all the necessary follow-up care and assessments. The total duration of your participation would involve the surgery, hospital stay, and ongoing follow-up visits, which can span over several months or even years to fully assess the device's long-term effects.

Potential risks and benefits

Participating in this study could potentially offer the benefit of a new treatment option for severe heart failure affecting both sides of your heart, which might improve your heart's ability to pump blood and potentially improve your quality of life when other options are limited. However, like any surgery involving heart devices, there are potential risks, including complications from the surgery itself, infections, blood clots, or device malfunctions. Your study doctors will explain all potential risks and benefits in detail, and it's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany

Common questions

What is biventricular heart failure?

It's a serious condition where both the left and right sides of your heart are too weak to pump enough blood around your body.

What is the DuoCor Ventricular Assist System?

It's a new medical device with two small pumps designed to help both the left and right sides of the heart pump blood at the same time.

Why is this device needed?

For some people with severe heart failure, other treatments don't work, and there aren't enough donor hearts for transplants. This device aims to fill that gap.

Will I have to take medication if I join the study?

Yes, it's expected that you would need to take certain medications, including blood thinners, to prevent complications with the device.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time without it affecting your medical care.

How to find out more

Lily Shi

shixiaoli@coretechmed.com +86 13418601356 Official trial record

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