RecruitingNAINTERVENTIONAL

Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

This research is looking at patients aged 65 to 75 who have a serious heart condition called symptomatic severe aortic stenosis. This means their aortic heart valve is very narrow, causing symptoms like breathlessness. The study compares two treatments: open-heart surgery (SAVR) to replace the valve, and a less invasive 'keyhole' procedure (TAVR) that replaces the valve using a thin tube. The main goal is to find out if the keyhole procedure is just as effective and safe as open-heart surgery for this age group. This could help doctors decide the best way to treat patients in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Ceric Sàrl

Enrolment target

1,180

Start

15 May 2025

Estimated completion

01 Sep 2037

Symptomatic Severe Aortic Stenosis

What is this study about?

This study, called "Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients," is designed to help us understand the best way to treat a common heart problem in people aged 65 to 75. The problem is called severe aortic stenosis. This happens when the main valve in your heart (the aortic valve) doesn't open properly because it has become stiff and narrow. This makes your heart work much harder to pump blood, which can lead to symptoms like feeling tired, out of breath, or having chest pain.

Currently, there are two main ways to fix this. One is traditional open-heart surgery (called SAVR), where the chest is opened, and the faulty valve is replaced. The other is a newer, less invasive procedure called TAVR (often referred to as a 'keyhole' procedure). In TAVR, a new valve is put in place using a thin tube threaded through a blood vessel, usually in the leg, without opening the chest.

This research wants to find out if the TAVR 'keyhole' procedure is just as safe and effective as open-heart surgery for people in this particular age group (65 to 75). By comparing the two treatments, doctors hope to gain a clearer picture of which option provides the best outcomes for patients, helping them make more informed decisions about your care.

Key takeaways

The study compares two ways to fix a narrow heart valve: open-heart surgery or a 'keyhole' procedure.
It's for people aged 65 to 75 with a specific heart condition called severe aortic stenosis.
The goal is to see if the 'keyhole' procedure is as good as traditional surgery for this age group.
Participation means you'd be randomly assigned to one of the two treatments.
The findings could help doctors decide the best treatment for future patients.

Who may be eligible?

To join this study, you would need to be between 65 and 75 years old. You must also have severe aortic stenosis that is causing you symptoms, meaning your heart valve is very narrow and causing problems like breathlessness or chest pain. Importantly, a team of heart doctors and surgeons would need to agree that both open-heart surgery and the 'keyhole' valve replacement procedure are suitable options for you.

However, some reasons might mean you can't take part. For example, if you have another serious illness that means you're not expected to live for at least another year, or if you're allergic to certain common medicines like aspirin or clopidogrel. It's also important that you can understand and follow the study instructions. If you're already involved in another medical trial that hasn't finished, you might not be able to join this one until the first study is complete.

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 65 and 75 years old?
Do you have severe aortic stenosis that is causing you symptoms?
Has a heart team said that both open-heart surgery and the 'keyhole' procedure are options for you?
Are you able to understand and follow instructions for a study?
Are you not allergic to common medications like aspirin or clopidogrel?

Answer every question to see your result.

What does participation involve?

This study will involve up to 1180 patients across different hospitals. If you take part, you would be randomly chosen (like flipping a coin) to either have the open-heart surgery to replace your valve or the 'keyhole' procedure. This is a multinational study, meaning it's happening in different countries. After your procedure, the doctors will closely monitor your health and recovery. You'll have regular check-ups to see how you're doing, and the study team will collect information about your health over time. The exact number of visits and the total length of follow-up would be explained to you in detail.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving one of the leading treatments for your heart condition, with careful monitoring from medical experts. It will also help improve our understanding of which treatment works best for certain patients. However, as with any medical procedure, there are potential risks associated with both open-heart surgery and the 'keyhole' procedure, such as bleeding, infection, or other complications. These risks would be fully explained to you before you agree to take part. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (49)

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

Medical University of Graz
Verified postcode
Graz, Austria· Recruiting
University Hostpital Sankt Pölten
Verified postcode
Sankt Pölten, Austria· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
North-Estonia Medical Centre Foundation
Verified postcode
Tallinn, Estonia· Recruiting
CHU Lille
Verified postcode
Lille, France· Recruiting
Infirmerie Protestante de Lyon
Verified postcode
Lyon, France· Recruiting
Massy-Hôpital Jacques Cartier
Verified postcode
Massy, France· Recruiting
CHU de Rouen
Verified postcode
Rouen, France· Not yet recruiting
Clinique Pasteur
Verified postcode
Toulouse, France· Recruiting
University Hospital Frankfurt
Verified postcode
Frankfurt, Germany· Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Not yet recruiting
German Heart Munich
Verified postcode
München, Germany· Not yet recruiting

Common questions

What is symptomatic severe aortic stenosis?

It's a serious heart condition where your heart's main valve is very narrow, making it hard for blood to flow and causing symptoms like dizziness or shortness of breath.

What are the two treatments being compared?

One is traditional open-heart surgery (SAVR), and the other is a less invasive 'keyhole' procedure (TAVR) to replace the faulty heart valve.

Why is this study important?

It will help doctors understand which method of replacing the heart valve is safest and most effective for people aged 65 to 75 with this condition.

Will I get to choose which treatment I receive?

No, you would be randomly assigned to receive either the traditional surgery or the 'keyhole' procedure, like drawing lots.

Can I leave the study if I change my mind?

Yes, you are completely free to withdraw from the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Philippe Garot, MD

pgarot@angio-icps.com +330160134602 Official trial record

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