CompletedObservational

Identifying the most important signs of frailty to predict outcomes after minimally invasive heart valve insertion

This study aims to understand how frailty, which is how well your body can bounce back from illness, influences the results for people undergoing a specific heart valve procedure called TAVI. TAVI is a way to replace a narrowed heart valve without major surgery. We know that being frail can mean a person might not recover as well after TAVI. Currently, it's hard to measure frailty accurately. This research will use CT scans and other simple tests like walking speed and grip strength to find better ways to identify frailty. The goal is to discover which patients are most likely to improve their symptoms and quality of life after a TAVI procedure, helping doctors make the best decisions for each individual's care.

At a glance

Status

Completed

Sponsor

University Hospitals Sussex NHS Foundation Trust

Enrolment target

826

Start

13 Mar 2025

Estimated completion

31 Jan 2026

Frailty and its relationship to outcomes in people undergoing transcatheter aortic valve implantation

What is this study about?

When someone has a heart valve that is very narrow (called severe aortic stenosis), they might need a new one. One way to do this is a special procedure called Transcatheter Aortic Valve Implantation (TAVI). This is a less invasive surgery where doctors insert a new valve through a tube, often in the leg, without opening the chest. It's usually done quickly and doesn't involve big cuts. While TAVI is generally safe, there are still some small risks. So, it's important for doctors to know which patients will truly benefit from it, meaning they'll feel better, have a better quality of life, and live longer.

As we get older, our bodies naturally have less 'reserve' to bounce back from illness or injury. Doctors call this 'frailty.' Frailty can be different for everyone. We already know that if someone is very frail, they might not recover as well after a TAVI procedure. Currently, doctors try to assess frailty, but it can be tricky, and the methods used aren't always precise. This study wants to find better and more accurate ways to understand frailty in patients considering TAVI. We're particularly interested in whether information from routine CT scans, which patients already have, can help.

The main goals of this study are twofold. First, we want to see if specific measurements from CT scans can help predict how well a patient will do after TAVI. We'll compare these scan results with how doctors currently assess frailty. Secondly, we want to combine these CT scan findings with other simple tests (like how fast someone walks or their grip strength) to figure out which patients will gain the most improvement from the TAVI procedure. Ultimately, this research aims to help doctors make more informed decisions, ensuring TAVI is offered to those who will benefit from it the most.

Key takeaways

This study aims to improve understanding of frailty in TAVI patients.
It uses existing CT scans and simple physical tests.
The goal is to predict who benefits most from TAVI.
Your TAVI treatment won't change if you participate.
No extra medical procedures are involved beyond standard care.

Who may be eligible?

This study is looking for two groups of people to take part. The first group includes people who have already had a TAVI procedure at least five years ago and are over 18 years old. We'll be looking back at their health information and CT scans from that time.

The second group is for people who are currently being considered for a TAVI procedure. To join this group, you must be 18 years or older and already have a CT scan as part of your usual medical checks before the TAVI. You also need to be able to do some simple assessments, like walking tests, and attend follow-up appointments.

You won't be able to join the study if certain conditions apply. For example, if you don't have a CT scan available for review, or if the scan quality isn't good enough. Also, if you've previously asked that your medical data not be used for research, or if your TAVI procedure is an emergency, you wouldn't be able 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.

Are you over 18 years old?
Are you currently being considered for a TAVI procedure?
Have you already had a CT scan for your TAVI assessment?
Can you complete some simple walking and strength tests?
Are you able to attend your usual follow-up appointment about 3 months after TAVI?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, what you do will depend on whether you are in Phase 1 or Phase 2. People in Phase 1 have already had their TAVI procedure some years ago. For them, we will look at their existing medical records and pre-procedure CT scans anonymously. They won't need to do anything new for the study.

For people in Phase 2, who are currently waiting for a TAVI, you would first be asked by your usual heart team if you're interested. If you agree, a member of the research team will explain more. Your TAVI procedure will go ahead exactly as planned, as per your normal care, and the study won't change anything about it. Before your procedure, we would ask you to do some short, simple tests like measuring your walking speed and grip strength. You'll also complete a short questionnaire about your symptoms and how you feel, and we'll record some standard blood test results.

After your TAVI, at your usual follow-up appointment about three months later, a research team member will repeat those same walking tests and questionnaires. This is the final part of the study for you. Afterwards, you'll simply continue with your regular medical care. The study aims to gather information from existing scans and these few extra tests, not to change your treatment.

Potential risks and benefits

Because this study is about understanding frailty better for future patients, there are no direct health benefits for individuals taking part. Your TAVI procedure and follow-up will happen as normal, whether you join the study or not. However, we hope that the information we gather will help us identify which patients will benefit most from TAVI in the future, improving care for everyone. We don't believe there are any extra risks involved in joining this study, as you won't undergo any additional procedures or changes to your care plan. All the normal risks associated with the TAVI procedure itself will still apply, as this is part of your routine treatment. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Sussex Cardiac Centre
City only
Brighton, England

Common questions

What is 'frailty' in simple terms?

Frailty describes how well your body can cope with stress, illness, or injury, and how easily you bounce back. It's about your body's overall strength and resilience.

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a way to replace a narrowed heart valve using a thin tube inserted through a blood vessel, usually in the leg, without needing open-heart surgery.

Will my treatment change if I join the study?

No, your planned TAVI procedure and all your usual medical care will continue exactly as normal. The study does not change your treatment.

What extra tests will I have if I join?

If you are having a TAVI, you would do some short, simple tests like walking speed and grip strength, and answer questionnaires about your health, both before and a few months after your procedure.

How long will the study run for?

The study itself is planned to run from March 2025 to May 2026. Your individual participation would involve those few assessments around your TAVI time.

How to find out more

Jessica Parker

jessica.parker21@nhs.net +44 (0)1273 696955 Official trial record

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