RecruitingNAINTERVENTIONAL

OPTImal Treatment of Sinus VENOSUS Defect

This study looks at a heart condition called Sinus Venosus Defect (SVD), which is a type of 'hole in the heart' affecting how blood flows. For a long time, surgery was the only way to fix it. Now, there's a newer treatment involving a special "covered stent" (a small mesh tube) that can be put in without major open surgery. This trial, called OPTIVENOSUS, aims to compare this new stent method with traditional surgery. Researchers want to find out if the stent procedure is just as safe and works just as well as surgery, potentially offering another option for patients, especially adults. They're also checking how it affects patients' quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Chirurgical Marie Lannelongue

Enrolment target

Start

12 May 2023

Estimated completion

12 May 2029

Sinus Venosus Defect Congenital Heart Disease Sinus Venosus Atrial Septum Defect

What is this study about?

This study is about a heart condition known as Sinus Venosus Defect (SVD). This is a type of "hole in the heart" (doctors call it a congenital heart disease) that you're born with. It means some blood flows in the wrong direction within your heart due to an abnormal connection, which can put extra strain on the heart over time. For many years, the main way to correct this problem was through open-heart surgery.

More recently, a new treatment has emerged that uses a special flexible tube called a "covered stent." This stent is inserted into a blood vessel and guided to the heart to fix the problem without the need for large incisions. This trial, called OPTIVENOSUS, is comparing this newer stent method with the traditional surgery. The main goals are to see if the stent procedure is as safe and effective in fixing the heart defect as surgery, and how it affects patients' overall well-being and daily life. The study will also help doctors understand when the stent might be a better option than surgery for certain patients.

The project is based in France and involves several hospitals. Before any procedure, experts will use detailed scans and even 3D models to plan the best approach for each patient. They want to ensure that if the stent is used, it fits correctly and will work. They hope to show that the stent treatment can provide similar good results to surgery, potentially offering another important choice for people with SVD, particularly adults.

Key takeaways

This study compares a new stent treatment with traditional surgery for a heart condition called Sinus Venosus Defect (SVD).
It aims to see if the stent procedure is as safe and effective as surgery, especially for adults.
Detailed scans and a team of specialists will decide the best treatment for you.
Participation involves initial assessments and follow-up for at least six months.
It could offer a less invasive treatment option but has potential risks, like any medical procedure.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would need to be at least 12 years old. You must have been diagnosed with a Sinus Venosus Defect that is causing your heart to work harder, and your doctors have recommended that it needs to be fixed. If you are an adult, you'll need to understand the study and agree to take part by signing a consent form. If you are under 18, your parents or guardians would need to agree that your information can be used for the study.

Patients who are pregnant or breastfeeding, already in another medical study, or unable to freely give consent (for example, if under guardianship) would not be able to participate. Also, if you are under 18, you would only be considered for the traditional surgery part of the study, not the new stent procedure.

A team of heart specialists will carefully review your scans and health to decide if either surgery or the stent procedure is suitable for you. They will consider factors like your age, other health conditions, and the specific details of your heart defect to determine the best treatment path.

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 12 years or older?
Do you have a Sinus Venosus Defect that needs fixing?
If an adult, are you able to understand and sign consent forms?
Are you not pregnant or breastfeeding?
Are you not currently part of another medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a detailed assessment. This involves scans like CT and MRI to get clear pictures of your heart, as well as tests like a 6-minute walk test to check your fitness, a heart monitor (Holter), and an ECG to look at your heart's electrical activity. Your scans will also be used to create 3D models to help the doctors plan.

A team of different heart specialists will then meet to discuss your specific case. They will decide if either the stent procedure or surgery is the best option for you, based on your tests and overall health. If you are chosen for the stent procedure, this involves placing a special covered stent in your heart. If you are chosen for surgery, you would undergo the standard operation.

After your procedure, whether it's the stent or surgery, the study team will follow up with you regularly for at least six months. This follow-up will include checks on how well the treatment worked, your health, and your quality of life. The total duration of your active involvement in the study's follow-up will be explained by your doctor.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, less invasive treatment option for your heart condition, which could lead to a faster recovery compared to traditional surgery. However, like any medical procedure, both the stent placement and surgery carry potential risks, such as bleeding, infection, or other complications. The team will carefully monitor you for these. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
Hospices Civils de Lyon
Verified postcode
Bron, France· Not yet recruiting
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
CHU Grenoble
Verified postcode
Grenoble, France· Recruiting
Sébastien HASCOËT
Verified postcode
Le Plessis-Robinson, France· Recruiting
CHU Lille
Verified postcode
Lille, France· Recruiting
Hôpitaux universitaire de Marseille
Verified postcode
Marseille, France· Not yet recruiting
CHU Nantes
Verified postcode
Nantes, France· Not yet recruiting
CHU Necker APHP Paris
Verified postcode
Paris, France· Not yet recruiting
HEGP Paris
Verified postcode
Paris, France· Not yet recruiting
CHU Toulouse
Verified postcode
Toulouse, France· Not yet recruiting
Clinique Pasteur, Toulouse
Verified postcode
Toulouse, France· Not yet recruiting

Common questions

What is a Sinus Venosus Defect?

It's a type of 'hole in the heart' that you are born with. It affects how blood flows, causing some blood to go in the wrong direction.

What is a 'covered stent'?

It's a small, flexible mesh tube covered with material that can be placed inside a blood vessel to redirect blood flow and fix the heart defect without major surgery.

Will I have to have surgery if I join the study?

Not necessarily. The study is comparing the new stent procedure with traditional surgery. A team of heart specialists will decide which treatment is best for you.

How long will I be followed in the study?

You will be followed up for at least six months after your procedure to check on your health and the success of the treatment.

Can children under 12 join this study?

No, this study is for patients aged 12 years and older. For those under 18, only the surgical treatment option will be considered within the study.

How to find out more

SEBASTIEN HASCOËT

s.hascoet@ghpsj.fr +33140942429 Official trial record

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