Not yet recruitingOBSERVATIONAL

Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)

The QualiTAVI-UK study is looking at how a heart procedure called TAVI (Transcatheter Aortic Valve Implantation) affects people's lives in the long run. TAVI is a way to replace a faulty heart valve without major open-heart surgery, helping those with a serious condition called severe aortic stenosis. While we know TAVI works, doctors want to understand more about how it impacts daily living, including physical and mental health. This study, based at Derriford Hospital in Plymouth, will be the first of its kind in the UK to look at quality of life from the start for patients having TAVI. The findings will help doctors make better decisions and explain more clearly what patients can expect after this important procedure.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital Plymouth NHS Trust

Enrolment target

100

Start

01 Nov 2025

Estimated completion

01 Feb 2027

TAVI(Transcatheter Aortic Valve Implantation)TAVI Quality of Life Mental Health

What is this study about?

This study, called QualiTAVI-UK, is all about understanding how a heart procedure called TAVI – that's short for Transcatheter Aortic Valve Implantation – affects people's daily lives and well-being. TAVI is a way to replace a narrowed heart valve (called aortic stenosis) without needing open-heart surgery. It's often used for people who might be too unwell for traditional surgery. We know TAVI successfully treats the heart problem, but doctors want to learn more about how much better people feel emotionally and physically after having it.

At the moment, most of what we know about TAVI's impact on quality of life comes from looking back at old patient records. This study is different because it will follow patients from the very beginning, before their TAVI procedure, and then for several months afterwards. This 'forward-looking' approach gives a clearer picture. It's happening at Derriford Hospital in Plymouth and will be the first study of its kind in the UK focused specifically on quality of life improvements after TAVI.

The main goal is to get a really good understanding of how TAVI changes things for patients, not just for their heart, but for their overall happiness, ability to do daily tasks, and mental health. The results will be very helpful for doctors to guide future decisions about TAVI and to explain to patients what they can realistically expect in terms of feeling better and living a fuller life after their procedure.

Key takeaways

This study aims to understand how TAVI improves everyday life.
It will look at both physical and mental well-being.
It's the first UK study to follow TAVI patients prospectively for quality of life.
Your input helps doctors make better decisions for future patients.
Taking part involves filling out health questionnaires over a few months.
Participation is voluntary and won't affect your medical care.

Who may be eligible?

To be part of this study, you would need to be a patient who has been told by your medical team that you are suitable for the TAVI procedure and have agreed to have it. There are no age restrictions, so patients of all ages who are having TAVI can potentially join.

The most important thing is that you agree to take part in the research. If someone decides they don't want to be involved in the study, then they wouldn't be included. This is a choice you always have.

So, if you're scheduled for a TAVI procedure at Derriford Hospital, you might be asked if you'd like to participate.

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.

Am I having a TAVI procedure soon?
Has my doctor said I am suitable for TAVI?
Am I a patient at Derriford Hospital (University Hospitals Plymouth)?
Would I be happy to fill out a few questionnaires about how I'm feeling?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it won't change your medical care or your TAVI procedure itself. The main thing you'll do is fill in a few health questionnaires. These questionnaires will ask about your physical health, your mental well-being, and how well you can do everyday things.

You'll be asked to complete these questionnaires at a few different times: when you are first referred for TAVI, just before your procedure, and then again 30 days and 3 months after your TAVI. There are no extra hospital visits specifically for the study researchers beyond your usual follow-up appointments. The entire study period for each patient lasts about 3 months, although the hospital will be collecting information from all patients over a full year.

Potential risks and benefits

Taking part in this study does not involve any medical risks beyond those of the TAVI procedure itself, which your doctor will discuss with you. The main benefit is that your experiences will help doctors and other patients in the future understand more about how TAVI can improve quality of life. The only 'disadvantage' might be the time it takes to fill out the questionnaires. You are always free to change your mind and withdraw from the study at any point, without it affecting your medical care.

Locations (1)

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

Derriford Hospital
Verified postcode
Plymouth, United Kingdom

Common questions

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a keyhole heart procedure to replace a faulty heart valve without major open-heart surgery.

What does 'Quality of Life' mean in this study?

It means how happy and well you feel emotionally and physically, and how easily you can do your daily activities after your heart procedure.

Where is this study taking place?

The study is taking place at Derriford Hospital, which is part of University Hospitals Plymouth in the UK.

Do I have to take part if I'm having TAVI?

No, taking part is completely your choice. Your medical care will be exactly the same whether you join the study or not.

How long will I be involved in the study?

You'll be asked to complete questionnaires at different times over 3 months after your TAVI procedure.

How to find out more

Ayman Helal, MD Cardiology

ayman.helal1@nhs.net +447376863806 Official trial record

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