RecruitingOBSERVATIONAL

Observational Study of Venus P-Valve

This study is checking how a new heart valve, called the Venus P-Valve, works in real life for people who have a specific heart condition. This condition, called 'Right Ventricular Outflow Tract Dysfunction', means there's a problem with the way blood flows out of the heart's right side to the lungs. Sometimes, the original valve doesn't close properly (pulmonary regurgitation) or is too narrow (pulmonary stenosis). Doctors are using a technique where they put in the new valve without major surgery. The study will follow people for up to five years to see how they get on and if the new valve helps them. It's for people aged 12 to 70 and aims to gather important information for healthcare regulators.

At a glance

Status

Recruiting

Sponsor

Venus MedTech (HangZhou) Inc.

Enrolment target

200

Start

26 Aug 2024

Estimated completion

01 Dec 2032

Right Ventricular Outflow Tract Dysfunction

What is this study about?

This study is focused on a new type of heart valve, called the Venus P-Valve, which doctors can put into the heart without needing major open-heart surgery. This procedure is known as 'transcatheter pulmonary valve implantation' (TPVI). The study is looking at people who have a heart problem called 'Right Ventricular Outflow Tract Dysfunction'. This basically means there's an issue with the main pathway that carries blood from the right side of your heart to your lungs.

For some people with this condition, the valve that controls blood flow to their lungs (called the pulmonary valve) isn't working as it should. It might not close properly, allowing blood to leak backwards (this is called pulmonary regurgitation), or it might be too narrow, making it harder for blood to flow through (this is called pulmonary stenosis). If you have one of these issues, your doctor might suggest a new valve.

The purpose of this study is to closely observe how the Venus P-Valve works for patients in their everyday lives. It's like watching how a new car performs once it's on the road, rather than just in a test lab. The information gathered will be shared with health authorities to help them understand if this new valve is a good and safe option for people who need it.

Key takeaways

This study evaluates a new heart valve (Venus P-Valve) for a specific heart condition.
The valve is fitted through a less invasive procedure.
It's for people aged 12-70 with a pulmonary valve problem.
Participants will have health checks for up to five years.
The goal is to gather information on how the valve works in real life.

Who may be eligible?

To join this study, people generally need to be between 12 and 70 years old. You must have a natural heart pathway for blood leaving the right side of your heart to your lungs, even if it's been repaired before. Importantly, you'll need to have a problem with your pulmonary valve – either it's leaking significantly, or it's too narrow, or both – and your doctor must believe you would benefit from a new valve.

You also need to be willing to take part and attend all the follow-up appointments for up to five years. If you're a child, your parent or legal guardian would need to agree for you to participate.

However, you wouldn't be able to join if you have certain other medical conditions or if you couldn't follow the specific instructions for the Venus P-Valve system. Your doctor will carefully check if this 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 between 12 and 70 years old?
Has your doctor said you have a problem with your heart's pulmonary valve (leaking or too narrow)?
Are you able to attend follow-up appointments for up to five years?
Do you (or your legal guardian, if you're under 18) understand what is involved and agree to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Venus P-Valve as part of your treatment. After the procedure, you'll have several follow-up appointments. There will be one just before you leave the hospital, then another after about 30 days. You'll also have check-ups at six months, one year, and then once a year for up to five years after your valve was fitted. During these visits, doctors will check how you are doing, ask about your health, and perform any necessary tests to see how the new valve is working. There are no specific medications given as part of the study; it focuses on observing the valve's performance. The total time you'd be involved in the study's follow-up is five years.

Potential risks and benefits

Taking part in this study means you would receive a new heart valve that aims to improve your heart condition. This could help with symptoms and improve your quality of life. As with any medical procedure, there are potential risks associated with fitting a new heart valve, which your doctor will discuss with you in detail. Being in a study also means more frequent check-ups, which can be reassuring. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

CHU Bordeaux
Verified postcode
Pessac, France· Not yet recruiting
Chu Nantes
Verified postcode
Nantes, France· Recruiting
Marie Lannelongue
Verified postcode
Le Plessis-Robinson, France· Recruiting
Hopital Necker-Enfants malades
Verified postcode
Paris, France· Recruiting
Heart CenterMunich
Verified postcode
Munich, Germany· Not yet recruiting
Clinic of Congenital Heart Disease
Verified postcode
Berlin, Germany· Not yet recruiting
OPBG Rome
Verified postcode
Rome, Italy· Not yet recruiting
S. Donato Milan
Verified postcode
Milan, Italy· Not yet recruiting
Leeds General Infirmary
Verified postcode
Leeds, United Kingdom· Not yet recruiting
Evelina Children's Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is the Venus P-Valve?

It's a special heart valve designed to help people whose own pulmonary valve isn't working properly. It can be put into place without major surgery.

What does 'Right Ventricular Outflow Tract Dysfunction' mean?

It's a medical term for a problem with the pathway that carries blood from the right side of your heart to your lungs.

How long will I be followed up in this study?

You will have regular check-ups for up to five years after the valve is put in, to see how you are doing.

Do I have to take special medicines if I join?

No, this study is about observing the valve itself, not testing new medicines. Your usual medications will continue as prescribed by your doctor.

Can I leave the study if I want to?

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

How to find out more

Cong Ma

macong@venusmedtech.com +86 18817939751 Official trial record

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