Not yet recruitingOBSERVATIONAL

Left Bundle Branch Area Pacing 3D Guidance System

This project is creating a new computer guidance system using artificial intelligence to help doctors place pacemaker leads more precisely. Specifically, it's for a type of pacing called Left Bundle Branch Area Pacing, which helps the heart beat more effectively in people with heart failure or a slow heartbeat. The system will use brain power from computers to create a detailed 3D map of a patient's heart. This map, based on MRI scans, will show areas of scarring and help doctors avoid them when fitting the pacemaker. The goal is to make the procedure safer and more successful, by guiding doctors to the best spot for the pacemaker lead.

At a glance

Status

Not yet recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

300

Start

01 Jul 2024

Estimated completion

31 May 2025

Left Bundle Branch Pacing Heart Failure Bradycardia

What is this study about?

Imagine your heart has electrical wires that tell it when to beat. Sometimes, these wires don't work quite right, leading to conditions like heart failure or a slow heartbeat (bradycardia). A pacemaker is a small device that can help by sending electrical signals to your heart, making it beat more regularly and strongly. One advanced way to do this is called Left Bundle Branch Area Pacing (LBBAP).

This study is all about making LBBAP even better. Doctors use a special wire, called a lead, which needs to be placed very carefully inside your heart. The aim of this project is to create a clever computer system that acts like a smart guide. This system uses information from detailed scans of your heart, like MRI scans, to build a 3D picture. This picture helps highlight any scar tissue in your heart, which doctors prefer to avoid when placing the pacemaker lead.

By using this new computer system, doctors hope to get real-time, personalised guidance during the procedure. This means they'll have a clearer view of your unique heart anatomy, including any scar tissue, projected onto the X-ray images they usually use. The idea is that this will help them put the pacemaker lead in the very best spot, making the procedure more successful and leading to better results for patients in the long run.

Key takeaways

Developing a smart computer system to improve pacemaker procedures.
Aims to help doctors place pacemaker leads more accurately.
Uses anonymous existing heart scans (MRI, CT, X-ray) from past patients.
No direct patient involvement or new procedures for this study.
Potential for better, safer treatments for future heart patients.

Who may be eligible?

This study is looking back at information from people who have already had certain heart procedures or scans. It's not recruiting new patients for treatment. Instead, it's using existing, anonymous medical imaging data to develop and test their new guidance system.

To be included, the original patients would have been over 18 years old. They would have participated in previous heart studies called TACTIC-CRT or Cardiac CT to guide CRT implantation, or had a specific type of pacemaker (LBBA pacing device) fitted in the last 10 years at GSTT, RBH, or ICH hospitals, and also had an MRI scan of their heart to check for scarring.

Patients who were under 18 years old, had certain heart conditions from birth (congenital heart disease), or didn't have an MRI scan before their LBBA pacing device was fitted are not included in the data used for this 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.

I'm not being asked to participate in a trial directly.
My medical records might be used if I had a specific pacemaker in the last 10 years and an MRI.
My data would only be used if I was over 18 at the time of my procedure/scan.
My data would not be used if I had a heart condition from birth.
My records would be used anonymously, meaning no one could identify me.

Answer every question to see your result.

What does participation involve?

Please note, this study is not asking people to take part directly in a new medical trial. Instead, researchers are using existing, anonymous medical records and imaging scans from people who have already had certain heart treatments or scans in the past. This means you wouldn't be asked to visit a clinic, have any new assessments, take medication, or have any follow-up appointments related to *this specific study*. Your personal information is not being used; only the medical scan data is being looked at anonymously to develop and test the computer system.

Potential risks and benefits

Since this study only uses anonymous, existing imaging data and medical records, there are no direct risks to patients. There are also no direct benefits to individual patients because no new treatments or procedures are being given. However, the potential benefit is that if this new guiding system works well, it could lead to safer and more effective pacemaker fitting procedures for future patients with similar heart conditions, improving their quality of life. As this involves reviewing past, anonymised data, the 'right to withdraw' in the traditional sense doesn't apply to individuals, as the data is already anonymised.

Locations (1)

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

Imperial College Nhs Healthcare Trust
Verified postcode
London, United Kingdom

Common questions

What is Left Bundle Branch Area Pacing?

It's a special type of heart pacing that aims to make your heart beat in a more natural and effective way, often used for people with heart failure or a slow heartbeat.

What is 'artificial intelligence' in this study?

It refers to smart computer programs that can learn from lots of data to help doctors create detailed maps of your heart and guide them during procedures.

Will I have an MRI scan if I join this study?

No, this study is only looking at MRI scans and other images that have already been taken from previous patients. No new scans are being done for this research project.

Is my personal information safe?

Yes, completely. The study only uses anonymised data, meaning all identifying information has been removed so no one can link the data back to you.

How long will this study take?

The study itself is focused on developing and testing the computer system using existing data. It doesn't involve any time commitment from individual patients.

How to find out more

Aldo Rinaldi, MD, MBBS, FRCP, FHRS

aldo.rinaldi@gstt.nhs.uk 0207 188 9275 Official trial record

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