RecruitingOBSERVATIONAL

Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart

This study, called a registry, is observing how a specific device, the EXCOR Venous Cannula, performs in patients with heart conditions where the right side of their heart isn't working properly. The main goal is to check its safety and see how well it helps patients. Researchers want to make sure any known risks are still acceptable and to spot any new problems that might come up. They'll also be tracking how much patients improve over time. This isn't a study where you get a new treatment; it's about watching how an existing device works in a real-world setting to gather more information.

At a glance

Status

Recruiting

Sponsor

Berlin Heart GmbH

Enrolment target

Start

01 Jun 2021

Estimated completion

01 Sep 2027

Heart Failure Univentricular Heart Ventricular Dysfunction Heart Diseases Cardiovascular Diseases

What is this study about?

Imagine your heart is a pump, and sometimes one side of it, often the right side, needs a little extra help. This study is exploring a device called an EXCOR Venous Cannula, which is used alongside a heart support system (an EXCOR VAD) to help hearts that are struggling.

The main aim of this study is to keep a close eye on how safe and effective this device is for patients. Doctors want to make sure that the benefits of using it continue to outweigh any potential downsides. They'll also be watching to see if any new problems appear over time. By carefully monitoring patients, they hope to learn more about how well the device helps people feel better and improve their health, both soon after it's used and much later on.

This isn't a trial testing a brand-new treatment. Instead, it's like a careful observation program. Doctors will be collecting information from patients who are already using or are about to use this device as part of their heart support. This helps them understand how the device works in a real-world setting, gathering valuable insights over time.

Key takeaways

It's an observational study, not a treatment trial.
The study monitors an existing heart support device (EXCOR Venous Cannula).
Aims to assess safety and how well patients improve over time.
Information is collected for up to 12 months per patient.
No new treatments are given as part of this study.
You can withdraw at any time.

Who may be eligible?

To be part of this study, you or your parent/guardian (if you're a child) must give your permission through a signed consent form. The doctors will also check if the EXCOR VAD heart support system is suitable for your specific heart condition, both for supporting the right side of the heart alone or both sides.

Your body size will also be considered; your body surface area (a measurement based on your height and weight) needs to be 1.2 square metres or more. Additionally, patients typically need to be on a transplant list or be considered a good candidate for a heart transplant.

If you can't give your consent, or if there are specific reasons why the EXCOR VAD is not considered safe or appropriate for your condition, then you wouldn't be able to join this study.

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.

Have I signed a consent form to participate?
Is the EXCOR VAD system considered suitable for my heart condition?
Do I have a body surface area of 1.2 square metres or more?
Am I on a heart transplant list or considered eligible for one?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you won't be receiving a new treatment as part of the study; instead, information will be collected about your health and how the EXCOR Venous Cannula is working for you. This is an observational study, meaning doctors will simply be watching and recording data as part of your normal medical care.

Over a period of up to 12 months after starting with the EXCOR VAD, doctors will gather details about your progress. This will include information from your regular hospital visits and check-ups. The full study plans to collect information from patients for about three and a half years in total, with individuals being followed for up to a year each.

Potential risks and benefits

As this is an observational study, you won't be given new treatments. The device being studied (the EXCOR Venous Cannula) is already in use. Potential benefits include contributing to a better understanding of how well this device works, which could help future patients. There are no additional risks beyond those usually associated with your medical care and the device itself, as doctors are simply gathering information. You are free to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

LMU Klinikum
Verified postcode
Munich, Germany· Recruiting

Common questions

What is the main purpose of this study?

It's to observe how safe and effective a specific heart support device (EXCOR Venous Cannula) is for patients with heart problems.

Will I receive new treatment in this study?

No, this is an observational study. You won't receive new treatments; doctors will just gather information about your care.

How long will I be involved in the study?

If you join, information about your health will be collected for up to 12 months.

Who can take part?

People with certain heart conditions who are using or will use the EXCOR VAD, typically those eligible for a heart transplant, and who give their consent.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Thomas Schöndorf, Dr. Dr. PD

clinical.science@berlinheart.de +49 30 81872600 Official trial record

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