Not yet recruitingNAINTERVENTIONAL

A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

This research is looking at a new type of heart valve, called the Venus-Neo Surgical Aortic Valve, for people who need to have their own aortic valve replaced. The main goal is to find out if this new valve is safe and effective. Doctors will carefully check how well the valve works and if it has any side effects. About 155 patients will be part of this study. Once they've had the new valve fitted, they'll be monitored regularly for about five years to see how they're doing. The whole study, from starting with the first patient to checking on the last one, will take around six years.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Jilin Venus Haoyue Medtech Limited

Enrolment target

155

Start

31 Oct 2023

Estimated completion

31 Oct 2029

Aortic Valve Disease Cardiovascular Diseases

What is this study about?

This study is about a new heart valve called the Venus-Neo Surgical Aortic Valve. Our hearts have four valves that control blood flow, and the aortic valve is one of them. For some people, this valve can become diseased and needs to be replaced. This study aims to see how safe and effective this new Venus-Neo valve is when used in patients who need their aortic valve replaced.

Doctors need to study new treatments very carefully to make sure they are safe and work properly. This study will involve about 155 patients who are already going to have an aortic valve replacement. Instead of receiving a standard valve, they will receive the Venus-Neo valve. The doctors will then keep a close eye on these patients for five years to see how well the valve performs over time.

The information gathered from this study will help doctors understand if the Venus-Neo valve is a good option for people with aortic valve disease in the future. It’s important to remember that this is a research study, and patients will be monitored very closely throughout the process.

Key takeaways

This study is testing a new heart valve for people needing a replacement.
It aims to see how safe and effective the Venus-Neo valve is over five years.
About 155 patients will be involved in the study.
Participation includes surgery and regular follow-up appointments.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you must be 18 years or older and have been told by your doctor that you need an aortic valve replacement. You also need to be able to attend all the follow-up appointments and understand what is involved in the study.

There are some reasons why you might not be able to join. For example, if you've already had a heart valve replaced or repaired, or if you've had major heart-related procedures recently. Certain other heart conditions, severe kidney or lung disease, or specific blood disorders might also mean you can't take part. The doctors will check all these things carefully to make sure the study is right for 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 18 years old or older?
Has your doctor told you that you need an aortic valve replacement?
Are you able to attend all follow-up appointments?
Have you *not* had any heart valves replaced or repaired before?
Do you *not* have certain other serious heart, kidney, or lung conditions?
Have you *not* had a stroke or mini-stroke recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have the Venus-Neo Surgical Aortic Valve implanted during your aortic valve replacement surgery. After your surgery, you'll have regular check-ups with the study team. These check-ups will help them see how well the new valve is working and if you have any side effects. You will be followed for a total of five years after your surgery, with all the necessary check-ups and tests. The entire study from start to finish for all patients is expected to last about six years.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be receiving a new heart valve that might offer good outcomes, though this is what the study aims to confirm. The potential risks are similar to those of any heart valve replacement surgery, including complications from the surgery itself or questions about the long-term performance of a new, unproven device. It's very important to know that you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Deutsches Herzzentrum Berlin-Charité
Verified postcode
Berlin, Germany

Common questions

What is the aortic valve?

The aortic valve is one of the four valves in your heart, controlling how blood flows from your heart to the rest of your body.

What does 'aortic valve replacement' mean?

It's a surgery where a damaged aortic valve is removed and replaced with a new, healthy valve.

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

If you take part, you will be followed for five years after your surgery to check on the new heart valve.

Is the Venus-Neo valve already approved for general use?

No, this is a study to evaluate if it is safe and effective enough for it to be approved for wider use in the future.

Can I leave the study if I change my mind?

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

How to find out more

Destino

nadia.destino@dhzc-charite.de +493045932260 Official trial record

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