RecruitingNAINTERVENTIONAL

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

This study is looking at the best way to replace an older, artificial heart valve that is no longer working well. Many people have a surgical heart valve replacement, and these valves can wear out over time. This trial compares two main types of new valves that can be put in without major open-heart surgery: one that expands with a balloon, and one that expands by itself. The study aims to see which type works better shortly after being fitted (at 30 days). This research is important because it will help doctors decide the best treatment options for patients needing a replacement valve, making sure they get the most suitable care for their heart condition.

At a glance

Status

Recruiting

Phase

Sponsor

Erasmus Medical Center

Enrolment target

600

Start

01 May 2021

Estimated completion

01 May 2029

Valve Heart Disease

What is this study about?

This research is looking into better ways to treat 'valve heart disease', specifically when an artificial heart valve that was put in during a previous operation starts to wear out. Many people have a surgical heart valve replacement using a valve made from animal tissue (called a bioprosthesis). These valves typically last 8-10 years before they might start to fail.

When an old valve fails, doctors can often replace it with a new one without needing another big open-heart surgery. This is done by guiding a new valve through a blood vessel, usually in the leg, and placing it inside the old, worn-out valve. This study compares two main types of these new replacement valves: those that are expanded into place using a small balloon, and those that expand on their own. The main goal is to see how well these new valves work in the first 30 days after they are put in.

By comparing these different types of valves, the study hopes to find out which one is safer and more effective. This information will help heart doctors make better decisions about which type of valve to use for patients whose previous artificial heart valve is failing. It's about ensuring patients get the best possible care for their heart condition.

Key takeaways

This study compares two types of replacement heart valves for people with a failing artificial heart valve.
It uses a less invasive procedure where a new valve is guided through a blood vessel, not open-heart surgery.
Researchers want to know which valve type works best shortly after being fitted (at 30 days) and long-term safety.
The study helps doctors choose the most suitable heart valve for patients in the future.
Participation involves receiving one of the tested new valves and being monitored for up to a year.
This study is for adults (18+) with a specific type of failing heart valve.

Who may be eligible?

To be considered for this study, you would generally need to be at least 18 years old. You would also need to have an artificial heart valve that was put in during a previous surgery, which is now failing. Importantly, your heart care team would need to agree that this type of valve replacement, done by guiding the new valve through a blood vessel (usually in your leg), is suitable for you after looking at detailed scans and tests.

There are also some reasons why someone might not be able to join. For example, if you are too unwell, or if the specific types of valves being tested are not suitable for your body. You also wouldn't be able to join if you have certain other heart problems like multiple faulty valves needing treatment, or if you've recently had a stroke or mini-stroke. This study is open to both men and women.

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 18 years old or older?
Do you have an artificial heart valve from a previous surgery that is now failing?
Has your heart care team suggested that this type of valve replacement might be suitable for you?
Have you *not* recently had a stroke or mini-stroke (in the last month)?
Do you *not* have other major heart valve problems needing treatment at the same time?
Are you generally stable and not needing advanced life support?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a new heart valve fitted using a method called 'transfemoral valve-in-valve TAVI'. This means a new heart valve will be guided through a blood vessel, usually in your leg, and placed inside your old, failing valve. You would be randomly assigned to receive either a 'balloon-expandable' type of valve (SAPIEN or MYVAL series) or a 'self-expanding' type of valve (EVOLUT series).

After the procedure, the study team will check how well the new valve is working. The main check will be at 30 days after the procedure. There will also be follow-up appointments and checks for safety over one year. This will involve monitoring for any health issues, such as needing to go back to hospital for heart failure, or any problems related to the valve. The exact number of visits and tests would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as receiving close medical attention and access to new treatments that might be suitable for your condition. However, there are also potential risks involved with any medical procedure or investigation, including those associated with placing a new heart valve, such as the chance of bleeding, infection, or other complications. The study aims to gather information to help future patients. You will receive a full explanation of all known risks and benefits, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Cedars Sinai
Verified postcode
Los Angeles, United States· Recruiting
Vienna General Hospital
Verified postcode
Vienna, Austria· Recruiting
St Paul's and Vancouver General Hospital
Verified postcode
Vancouver, Canada· Not yet recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Not yet recruiting
Institut Cœur Poumon
Verified postcode
Lille, France· Recruiting
Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
Verified postcode
Düsseldorf, Germany· Recruiting
University Hospital Mainz
Verified postcode
Mainz, Germany· Not yet recruiting
Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
Verified postcode
Athens, Greece· Recruiting
Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy
Verified postcode
Brescia, Italy· Recruiting
University Hospital of Padova
Verified postcode
Padua, Italy· Not yet recruiting
Erasmus Medical Centre
Verified postcode
Rotterdam, Netherlands· Recruiting
Centro Hospitalar de Lisboa Ocidental
Verified postcode
Lisbon, Portugal· Recruiting

Common questions

What is 'valve heart disease'?

It's a condition where one or more of your heart's valves don't work properly, affecting blood flow. This study focuses on a specific valve called the aortic valve.

What does 'TAVI' mean?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a way to replace a faulty heart valve without major open-heart surgery, usually by guiding a new valve through a blood vessel.

What does 'bioprosthesis' mean?

A bioprosthesis is an artificial heart valve made from animal tissue, often used in surgery. These valves can sometimes wear out over time.

Will I know which type of valve I'm getting?

In this study, you would be randomly assigned to one of the two main types of valves being compared. This is a common way to ensure the results are fair.

What are the main things the study is looking for?

The study's main goal is to see how well the new valves work 30 days after the procedure. It also checks safety over a year and compares how well different valve types perform.

How to find out more

Rutger-Jan Nuis, MD, PhD

r.nuis@erasmusmc.nl +31614858291 Official trial record

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