RecruitingNAINTERVENTIONAL

Remote Cardiovascular Monitoring in Post-TAVI Patients

This research is testing a new way to look after people after they've had a heart valve procedure called TAVI (Transcatheter Aortic Valve Implantation). The main idea is to see if using remote monitoring devices at home can help patients get out of the hospital sooner and prevent them from having to come back in. After TAVI, some patients can develop problems with their heart's electrical system, which might mean staying in hospital longer or needing a pacemaker. This study compares a group using special remote monitoring, which includes devices and a support system, with a group receiving the usual hospital care. We want to know if this new approach can lead to shorter hospital stays and fewer issues for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

216

Start

01 Nov 2024

Estimated completion

01 Jul 2028

Aortic Valve Stenosis Cardiac Conduction Disturbance Digital Health Transcatheter Aortic Valve Implantation TAVI

What is this study about?

When people have a special heart procedure called TAVI (Transcatheter Aortic Valve Implantation) to fix a narrowed heart valve, doctors want to make sure they recover well. Sometimes after TAVI, there can be changes in how the heart's electrical system works. These changes might mean people have to stay in hospital longer or even need a pacemaker.

This study is looking at a new way to check on people after their TAVI procedure. It's called 'remote monitoring'. This means using special devices that can keep an eye on your heart and health from your home. The doctors hope that by using this technology, they can spot any problems early, help you get home from the hospital quicker, and stop you from needing to come back in.

The study involves two groups. One group will use these remote monitoring devices and get support from a special system designed to help make decisions about their care. The other group will receive the standard care, which is what doctors usually provide. By comparing these two groups, the researchers want to find out if remote monitoring really can make a difference in how long people stay in hospital and if it can reduce any issues after TAVI. It's about finding the best and safest way to care for patients after this important heart procedure.

Key takeaways

This study helps doctors learn if remote monitoring after TAVI can reduce hospital stays.
It aims to find out if remote monitoring can prevent problems after the TAVI procedure.
Participants will either use remote monitoring devices or receive standard care.
The goal is to improve care and understand better ways to look after TAVI patients at home.
You have the right to withdraw from the study at any time.
It is a research study, not a guaranteed new treatment for you personally.

Who may be eligible?

To join this study, you need to be at least 18 years old and have recently had a TAVI procedure. The doctors would need to feel you are ready to go home on the same day as your procedure, meaning you haven't had any major problems like serious bleeding, strokes, or fluid around your heart that would require you to stay in hospital.

You also need to be able to walk comfortably after your procedure and have access to a smartphone or similar device, as well as someone around to support you if needed. It's important that you can understand the study information and agree to take part.

You wouldn't be able to join if you are very unwell after your TAVI, for example, if you had a heart attack, stroke, or severe bleeding. Also, if you already have a pacemaker, or if the TAVI procedure itself wasn't fully successful, or if you couldn't use the technology or communicate well with the study team, you wouldn't be able to take part.

Quick self-check

Are you 18 years old or older?
Have you recently had a TAVI procedure?
Are your doctors planning for you to go home the same day?
Do you have good social support at home?
Do you have access to a smartphone or similar device?
Can you understand and agree to take part in the study?

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

What does participation involve?

If you decide to take part in this study, you will be randomly placed into one of two groups. This is like flipping a coin – it's completely by chance. One group will receive special remote monitoring, and the other will get the usual care you would expect after your TAVI procedure.

If you're in the remote monitoring group, you'll receive four special devices to monitor your health from home. You'll also get support guided by information from these devices. If you're in the usual care group, you'll simply follow the standard medical advice and check-ups. The study will mainly focus on how long you stay in hospital after your TAVI and if you have any problems afterwards. The total duration of your participation in the study is not specified, but the aim is to see effects on hospital stays and events within 30 days and potentially up to 3 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring if you are in the remote monitoring group, which could potentially help spot problems early. However, there's no guarantee that participating will directly improve your health. If you are in the usual care group, you will receive the standard excellent care. As with any new technology, there might be technical issues with the remote monitoring devices, though every effort will be made to minimise these. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

Hammersmith Hospital
London, United Kingdom· Recruiting

Common questions

What is TAVI?

TAVI is a procedure to replace a narrowed heart valve (aortic valve) without open-heart surgery, using a thin tube called a catheter.

What is remote monitoring?

Remote monitoring means using small devices at home to send information about your heart and health to your doctors without you needing to visit the hospital.

Will I have to pay for anything?

No, you will not have to pay for any of the devices or care directly related to your participation in the study.

What if I have problems at home?

The study aims to detect potential problems early. You would continue to have access to your usual medical team and emergency services if needed.

How long will I be in the study?

The study aims to observe effects on hospital stays and future events, potentially up to 3 months, though the exact duration for individual participation is not detailed.

How to find out more

Badr Al Harbi, BScEMS, MSc

b.al-harbi23@imperial.ac.uk +44(0)7771429219 Official trial record

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