RecruitingOBSERVATIONAL

REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

This study focuses on patients whose TAVI heart valve, a replacement valve put in using a keyhole method, starts to fail over time. We're investigating different ways to treat this. One main treatment is 'Redo TAVI,' where a new valve is placed inside the old one through a keyhole. We're also looking at open-heart surgery to replace the valve, or managing the condition with medicines alone. The main goal is to understand how well these treatments work in both the short and long term, and to discover which patients benefit most from each approach. This will help doctors make better decisions for people needing further heart valve treatment.

At a glance

Status

Recruiting

Sponsor

The Leeds Teaching Hospitals NHS Trust

Enrolment target

550

Start

12 Dec 2024

Estimated completion

01 Mar 2033

Aortic Valve Stenosis

What is this study about?

When your aortic heart valve, which helps blood flow correctly from your heart, becomes narrowed or leaky, doctors can often fix it using a procedure called TAVI. This is a keyhole operation where a new valve, usually made from animal tissue, is put into place. It’s a very good treatment and helps many people feel much better.

However, like any tissue, these replacement valves don't last forever and can wear out over time. When your TAVI valve starts to fail, your doctors will need to decide the best way to help you. This study is looking closely at the different options available when this happens. One important option is called 'Redo TAVI.' This is another keyhole procedure where a new TAVI valve is placed inside the old, failing one.

We want to understand how well Redo TAVI works for patients, both soon after the procedure and in the years that follow. We're also comparing Redo TAVI to other treatments, such as open-heart surgery to replace the valve, or simply using medications to manage the problem. By doing this research, we hope to give doctors the crucial information they need to choose the very best treatment plan for each patient whose TAVI valve needs attention, helping everyone achieve the best possible health outcomes.

Key takeaways

This study helps doctors learn the best ways to treat a failing TAVI heart valve.
It focuses on Redo TAVI (a new valve inside an old one) and other treatments.
No experimental treatments; information is collected from usual medical care.
Helps improve future care for patients with worn-out TAVI valves.
Participation is voluntary and won't affect your treatment.

Who may be eligible?

This study is for adults whose TAVI heart valve, which they had put in previously, is now showing signs of failure and might need another treatment.

There are some reasons why someone might not be able to join the study. For example, if the problem with your valve is only due to a specific type of leak around the edge, or if you have an active infection in your heart (called endocarditis), or if you have blood clots that haven't been treated yet. Also, if doctors believe you have less than a year to live, or if you are pregnant or breastfeeding, this study would not be suitable.

Participants must also be at least 18 years old and able to legally agree to take part in the study.

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 a TAVI heart valve that doctors say is failing?
Are you currently pregnant or breastfeeding? (If yes, you likely can't join)
Do you have a serious active infection in your heart valves?
Are doctors expecting you to live for more than one year?

Answer every question to see your result.

What does participation involve?

This study primarily involves carefully watching and collecting information about your treatment and recovery. You won't be given any experimental treatments; instead, doctors will be recording details about the care you would receive anyway, whether it's a Redo TAVI, open-heart surgery, or managing your condition with medication. This includes details from your hospital stays, follow-up appointments, and any tests you have as part of your normal care. The study will track your health outcomes in the short term, immediately after treatment, and also over a longer period to see how you are doing months and years down the line. The exact duration of your participation will depend on your specific treatment path and follow-up schedule, but it will generally involve ongoing collection of health information.

Potential risks and benefits

Taking part in this study means doctors will closely monitor your health and the outcomes of your treatment. While there is no direct benefit to you from being in the study itself, the information gathered will greatly help doctors understand how to provide the best care for patients like you in the future. As the study only observes existing treatments, there are no additional medical risks beyond those of the treatments you would receive anyway. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (69)

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

Aalborg Universitethospital
Verified postcode
Aalborg, Denmark· Recruiting
Århus Universitetshospital
Verified postcode
Aarhus, Denmark· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
HUS Helsinki University Hospital
Verified postcode
Helsinki, Finland· Recruiting
Turku University Hospital
Verified postcode
Turku, Finland· Recruiting
Clinical Saint Augustin - Elsan
Verified postcode
Bordeaux, France· Recruiting
Brest University Hospital Centre
Verified postcode
Brest, France· Recruiting
Henri Mondor University Hospital
Verified postcode
Créteil, France· Recruiting
ICPS Hôpital privé Jacques-Cartier
Verified postcode
Massy, France· Recruiting
Centre Hospitalier Universitaire de Montpellier
Verified postcode
Montpellier, France· Recruiting
University Hospital of Nimes
Verified postcode
Nîmes, France· Recruiting
Hospital Marie Lannelongue
Verified postcode
Paris, France· Recruiting

Common questions

What is 'Redo TAVI'?

Redo TAVI is a keyhole procedure where a new heart valve is placed inside an older, failing TAVI valve that was put in before.

Why is my TAVI valve failing?

TAVI valves are made mostly from animal tissue, and over time, this tissue can naturally wear out or break down, causing the valve to stop working as well.

Will I have to have any extra tests for this study?

No, this study only collects information from tests and appointments you would have as part of your standard medical care; no extra procedures are needed just for the study.

What if I decide I don't want to be in the study anymore?

You can leave the study at any time without having to give a reason, and it will not affect the medical care you receive.

Does this study test new medicine?

No, this study observes and collects information about standard treatments for a failing TAVI valve, not new medicines or experimental procedures.

How to find out more

Dave Pickles

dave.pickles@nhs.net +441132433144 Official trial record

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