Active not recruitingNAINTERVENTIONAL

Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial

This study, called "The VIVA Trial," looks at two ways to treat severe aortic stenosis (a narrowed heart valve) in older patients. One is open-heart surgery to replace the valve, and the other is a less invasive procedure called TAVR, where a new valve is put in using a thin tube. This trial is specifically designed for patients whose heart valve opening is smaller than average. Researchers want to compare how well each method works, focusing on things like how smoothly blood flows through the new valve and whether patients experience serious side effects like stroke or severe bleeding. The aim is to find out which treatment is better and safer for this particular group of patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Enrolment target

300

Start

08 Aug 2017

Estimated completion

30 May 2027

Degenerative Aortic Valve Disease Aortic Stenosis Aortic Regurgitation

What is this study about?

Imagine your heart has a doorway, called the aortic valve, that opens and closes to let blood flow out to your body. If this doorway becomes narrow and stiff, it's called aortic stenosis. This makes your heart work harder and can cause symptoms like breathlessness or chest pain. When this problem becomes serious, the valve needs to be replaced.

There are two main ways to replace this valve. One is traditional open-heart surgery (called SAVR), where surgeons open the chest to replace the valve. The other is a newer, less invasive method called TAVR (Transcatheter Aortic Valve Replacement). With TAVR, doctors insert a thin, flexible tube (catheter) into a blood vessel, usually in the leg, and guide it up to the heart to place a new valve without open-heart surgery.

This study, called "The VIVA Trial," is special because it focuses on older patients (aged 65 and over) with severe aortic stenosis whose natural heart valve opening is quite small. Until now, we haven't had a proper study directly comparing SAVR and TAVR in this specific group of patients. The trial aims to find out which of these two procedures leads to better results for these patients, looking at things like how well the new valve works and whether there are significant health complications.

Key takeaways

Compares two heart valve replacement methods: surgery (SAVR) vs. less invasive (TAVR).
For older patients (65+) with severe aortic stenosis.
Specifically for patients with a smaller-than-average heart valve opening.
Aims to find out which treatment is better and safer for this specific patient group.
Participation involves being randomly assigned to a treatment and regular follow-up appointments.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for patients who are 65 years or older and have been diagnosed with severe aortic stenosis. This means their aortic valve opening is very narrow, making their heart work extra hard. Importantly, the study is specifically for those whose natural aortic valve is measured to be smaller than a certain size using special scans.

Some conditions would prevent you from joining. For example, if open-heart surgery is considered too risky for you, if you have a condition called "porcelain aorta" (where the main artery is very calcified), or if your main artery is too wide. Also, if you have severe narrowing in other heart arteries that can't be fixed, or if your aortic valve problem isn't due to calcium build-up, you wouldn't be able to participate.

Finally, if you have other serious valve problems that need surgery, or if you've already had a valve replaced in your aortic position, this study would not be suitable 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 65 years old or older?
Have you been diagnosed with severe aortic stenosis?
Have doctors confirmed your aortic valve opening is considered 'small'?
Have you been told that open-heart surgery is not too risky for you?
Do you not have any other severe heart problems that need immediate surgery?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive either the surgical valve replacement (SAVR) or the less invasive TAVR procedure. You wouldn't get to choose which one you receive, as this helps make the study fair. After your procedure, you would have regular check-ups and tests. This includes imaging scans to look at your new valve and make sure it's working well, along with routine health checks. The study team will explain exactly what these visits involve and how long you'll be followed up for, but typically, clinical trials follow patients for several years.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit from receiving one of the best available treatments for your heart condition, and you'll be closely monitored by a team of specialists. However, both surgery and TAVR carry their own risks, such as bleeding, infection, stroke, or heart rhythm problems, and the researchers cannot guarantee better outcomes than standard care. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

IUCPQ
Verified postcode
Québec, Canada

Common questions

What is severe aortic stenosis?

It's when your heart's main valve, the aortic valve, becomes very narrow and stiff, making it hard for blood to flow out of your heart.

What's the difference between SAVR and TAVR?

SAVR is open-heart surgery to replace the valve, while TAVR is a less invasive procedure where a new valve is placed using a thin tube through a blood vessel.

Why is this study only for people with a 'small aortic annulus'?

This refers to patients whose natural valve opening is smaller than average. There's less research comparing SAVR and TAVR specifically for this group, so the study aims to fill that gap.

Will I get to choose which treatment I receive?

No, if you join, you will be randomly assigned to either the TAVR or SAVR group. This helps ensure the study results are fair and unbiased.

How long does the study last?

The study will follow participants for several years to see the long-term effects of each treatment option.