RecruitingNAINTERVENTIONAL

Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

The VIVALL-2 study is comparing two different types of artificial heart valves, Allegra and Sapien, for people who have had an artificial valve put in before, but that valve is now worn out. This is called a 'valve-in-valve' procedure. Researchers want to see which of these new valves, put in without open-heart surgery, works best. The Allegra valve is designed to expand on its own, and the Sapien valve is expanded with a balloon. Both are used to fix a problem called aortic valve stenosis, where the heart valve doesn't open properly, or structural valve deterioration, where it's just not working as well as it should. The study will look at how well the new valves are working after 30 days and will involve patients in various countries.

At a glance

Status

Recruiting

Phase

Sponsor

Fundación EPIC

Enrolment target

104

Start

01 Feb 2024

Estimated completion

01 Nov 2026

Aortic Valve Stenosis Structural Valve Deterioration

What is this study about?

When the main valve in your heart, called the aortic valve, doesn't open properly or leaks, it can be a serious problem. Sometimes, people have surgery to replace this valve with an artificial one. However, over time, these artificial valves can also wear out or stop working well. When this happens, doctors sometimes suggest a procedure called 'valve-in-valve'. This means putting a new artificial valve inside the old, worn-out one, often without needing major open-heart surgery.

This study, called VIVALL-2, is looking at two different types of these 'new' valves: the Allegra valve and the Sapien valve. The Allegra valve is designed to expand on its own, while the Sapien valve is put in place and then expanded using a small balloon. Both are special types of heart valves that can be put in using a less invasive procedure. The main goal is to find out which of these two valves works better for people who need a replacement for their existing artificial heart valve.

Researchers will be looking closely at how well the new valves are working after about a month, specifically checking how easily blood flows through them. They will also check if the new valve fits properly without causing any problems. Understanding which valve works best can help doctors make better decisions for patients needing this important procedure in the future.

Key takeaways

This study compares two different replacement heart valves (Allegra and Sapien).
It's for people whose previous artificial heart valve is worn out.
The new valve is placed inside the old one, often without major surgery.
Patients are randomly assigned to receive one of the two valves.
The study checks how well the new valve works after 30 days.
Results could help doctors choose the best valve for future patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a serious problem with your existing artificial heart valve. This might mean it's very narrow (aortic stenosis) or leaking a lot, causing symptoms like feeling tired or breathless. Your heart care team must also agree that the 'valve-in-valve' procedure is the best option for you.

However, there are reasons you might not be able to join. For example, if you are pregnant, have an active infection, or have other serious health problems that mean you might not live for at least another year. You also can't be in the study if you're already taking part in another clinical trial, or if you refuse to take part.

Quick self-check

Are you 18 years old or older?
Do you have a serious problem with an artificial heart valve you had in the past?
Do your doctors think a 'valve-in-valve' procedure is right for you?
Are you able to attend follow-up appointments, including a scan at 30 days?
Are you not pregnant or already part of another medical trial?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, doctors will decide by chance (like flipping a coin) whether you receive the Allegra valve or the Sapien valve. This is called 'randomisation'. You won't get to choose which one you receive. After the procedure, you will need to have a special heart scan called an echocardiogram about 30 days later to check how well your new valve is working. The study team will also contact you around one year after your procedure to see how you are doing. The overall duration of your active participation, including follow-up, will involve these checks.

Potential risks and benefits

Taking part in a study like this could mean you receive a treatment that is as good as, or even better than, standard care. It also helps doctors learn more about the best ways to treat heart valve problems, which could benefit many people in the future. However, like any medical procedure, there are potential risks involved with having a new heart valve implanted, which your doctor will discuss with you. These risks are generally similar to those of the 'valve-in-valve' procedure itself, regardless of which specific valve is used. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (9)

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain· Recruiting
Hospital Clinico San Carlos
Madrid, Spain· Recruiting
Hospital Universitario de La Paz
Madrid, Spain· Recruiting
Hospital Universitario Puerta De Hierro
Majadahonda, Spain· Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, Spain· Recruiting
Hospital Universitari I Politècnic de La Fe
Valencia, Spain· Recruiting
Manchester University NHS Foundation Trust
Manchester, United Kingdom· Recruiting
Freeman Hospital
Newcastle, United Kingdom· Recruiting
Morriston Hospital, Swansea
Swansea, United Kingdom· Recruiting

Common questions

What is 'valve-in-valve'?

It's a procedure where a new artificial heart valve is placed inside an old, worn-out artificial valve, often without needing open-heart surgery again.

What's the difference between the Allegra and Sapien valves?

The Allegra valve expands on its own, while the Sapien valve is expanded using a balloon once it's in place. Both are types of artificial heart valves.

Will I get to choose which valve I receive?

No, if you join the study, a computer will randomly choose which of the two valves you receive. This ensures the study is fair.

What is the study hoping to find out?

It's comparing how well the two different valves work in people needing a 'valve-in-valve' procedure, mainly by checking blood flow and how well the valve fits after 30 days.

How long will I be involved in the study?

You'll have a check-up scan after about 30 days and then the study team will contact you around one year later to see how you're doing.

How to find out more

RAÚL MORENO GÓMEZ, MD, PhD

raulmorenog@hotmail.com 0034917277000 Official trial record

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