RecruitingNAINTERVENTIONAL

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

This study is testing a new 'Smart ECG system' designed to help doctors during heart pacemaker procedures. Specifically, it's for patients who need a special type of pacing called Left Bundle Branch Area Pacing (LBBAP) to treat slow heartbeats or improve heart function (Cardiac Resynchronisation Therapy). The system includes a portable ECG monitor and software that automatically measures important heart signals. Doctors hope this system will make it easier to correctly place the pacemaker wire in the heart, helping them to work more quickly and accurately during the operation. This study is about checking how well this new monitoring system works for these specific measurements.

At a glance

Status

Recruiting

Phase

Sponsor

MicroPort CRM

Enrolment target

Start

14 Nov 2025

Estimated completion

31 Mar 2026

Bradycardia Left Bundle Branch Area Pacing Cardiac Resynchronisation Therapy (CRT)ECG

What is this study about?

When your heart beats too slowly or inefficiently, doctors can implant a pacemaker. A pacemaker sends small electrical pulses to your heart to help it beat at a regular and healthy rhythm. Sometimes, doctors use a very specific way of placing one of the pacemaker wires, called Left Bundle Branch Area Pacing (LBBAP). This method aims to make your heart's natural electrical system work together as smoothly as possible, which can be very beneficial for people with certain heart conditions, like a very slow heartbeat.

During the pacemaker implant procedure, doctors need to know exactly where to place this special wire. To do this, they rely on an Electrocardiogram (ECG), which measures the electrical activity of your heart. This study is testing a new 'Smart ECG system' that doctors can use during the operation. This system is portable and designed to automatically measure key heart signals quickly. These measurements help the doctor confirm that the pacemaker wire is in the best possible position.

The main goal of this study is to see if this new Smart ECG system can accurately and easily provide the information doctors need to ensure the LBBAP pacemaker wire is placed correctly. By using this system, doctors hope to make the procedure more straightforward and efficient, allowing them to focus on safely placing the wire while getting immediate feedback on their progress.

Key takeaways

This study tests a new 'Smart ECG system' for pacemaker implants.
It aims to help doctors precisely place wires for Left Bundle Branch Area Pacing (LBBAP).
Participation involves using this system during your existing pacemaker surgery.
There are no extra medical procedures or risks involved for you.
The findings could improve future pacemaker operations for patients.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 or over and be having a pacemaker fitted that involves the special Left Bundle Branch Area Pacing (LBBAP) technique. This could be a brand-new pacemaker, or an update or replacement of an existing pacemaker.

There are some reasons why you wouldn't be able to join. For example, if you're unable to understand what the study involves, if you're under 18, or if you're a woman who could still have children (pre-menopausal). Also, if you have other electrical devices in your body that aren't related to your heart, you might not be suitable 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.

Are you 18 years old or older?
Are you having a pacemaker fitted that includes Left Bundle Branch Area Pacing (LBBAP)?
Are you able to understand what the study is about and give your consent?
Are you not currently pregnant or able to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would happen as part of your planned pacemaker implant procedure. You wouldn't need any extra hospital visits or follow-up appointments solely for this study. During your operation, while the doctors are fitting your pacemaker, they would use the new 'Smart ECG system' alongside their usual monitoring equipment. This means some additional ECG cables would be attached to you during the procedure. The doctors would use the system to guide their placement of the pacemaker wire. Your participation would conclude once your pacemaker implant procedure is finished.

Potential risks and benefits

Taking part in this study does not involve any additional medical procedures or changes to your treatment. The 'Smart ECG system' being tested does not touch your body and is used alongside standard care. Therefore, there are no expected extra risks to your health by participating. The potential benefit is that the information gathered could help improve pacemaker implant procedures in the future, making them more precise for other patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (4)

CHU de Besançon
Verified postcode
Besançon, France· Not yet recruiting
Clermont Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU Grenoble Alpes
Verified postcode
Grenoble, France· Not yet recruiting
Clinique du Millénaire
Verified postcode
Montpellier, France· Recruiting

Common questions

What is Left Bundle Branch Area Pacing (LBBAP)?

It's a special way doctors can place a pacemaker wire to help your heart's electrical system work better and more naturally, especially if your heart beats slowly.

What is the 'Smart ECG system'?

It's a portable monitoring device with software that helps doctors see and measure your heart's electrical signals quickly during a pacemaker operation, guiding them to place the wire correctly.

Will I have to do anything extra if I join the study?

No, you don't need extra visits or treatments. The study uses the new monitoring system during your planned pacemaker implant procedure.

Are there any extra risks involved?

The study device is a monitor that doesn't interact with your body and is used alongside your normal care, so there are no extra risks expected for you.

Can I change my mind about taking part?

Yes, you can decide not to take part or withdraw at any time, and this will not affect the medical care you receive.

How to find out more

Maria Martino, Project Manager

maria.martino@crm.microport.com +393351005007 Official trial record

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