Active not recruitingNAINTERVENTIONAL

Novel Approach to Conduction System Pacing With Use of Ultrasound

Every year, many people around the world get pacemakers, usually with the help of X-rays. Doctors are trying to find the best spot in the heart for the pacemaker wire (lead) to go. A promising area is called the left bundle branch area (LBBA), which is deep inside the heart. However, X-rays aren't perfect for seeing this area clearly, which can mean longer procedures and more X-ray exposure for patients and staff. This study aims to find out if using ultrasound, a different type of scan, can help guide the pacemaker lead more accurately into the LBBA. We hope this could lead to quicker procedures, less radiation, and better results for patients needing a pacemaker.

At a glance

Status

Active not recruiting

Phase

Sponsor

Habib Khan

Enrolment target

152

Start

10 Apr 2025

Estimated completion

28 Feb 2029

Conduction Block, Atrioventricular Bundle-Branch Block

What is this study about?

When someone needs a pacemaker, doctors implant a small device that helps regulate their heart rate. Traditionally, X-rays are used to guide the doctor when placing the tiny wire, or 'lead,' into the heart. While X-rays are helpful, they don't give a complete picture of the whole heart in detail, especially a key area called the left bundle branch area (LBBA), which is deep inside. Placing the lead here is thought to be very effective, but because it's hard to see perfectly with X-rays, the procedure can take longer, and both patients and hospital staff are exposed to more radiation. Too much X-ray exposure over time can carry health risks, including a slightly increased chance of developing certain medical conditions.

This research project is exploring a new approach. Instead of relying mostly on X-rays, we want to see if using ultrasound scans can provide a clearer and more precise view during pacemaker lead placement, especially into the LBBA. Ultrasound uses sound waves to create images of the inside of your body, without any radiation. By potentially seeing the heart more clearly, doctors might be able to place the lead more accurately and with fewer attempts.

Ultimately, if this study shows that ultrasound guidance is effective, it could mean several good things for people needing pacemakers. We hope it could lead to safer procedures with less radiation exposure, more accurate lead placement for better long-term heart function, and potentially shorter surgery times. Shorter procedures could also mean that more patients can receive their pacemakers sooner, reducing waiting lists.

Key takeaways

This study tries a new way to fit pacemakers using ultrasound scans.
The goal is safer, more accurate lead placement, less X-ray exposure.
It focuses on placing the pacemaker lead in a key heart area (LBBA).
May lead to quicker procedures and better patient outcomes.
Participation involves your pacemaker implant procedure with ultrasound guidance.

Who may be eligible?

To join this study, you need to be at least 18 years old and due to have a specific type of pacemaker fitted because of certain heart rhythm problems. It's important that you understand what the study involves and are happy to sign a form giving your permission to take part, and that you're able to follow the study instructions. We'll also check the quality of your heart images using a routine echocardiogram to make sure they're clear enough for the study.

There are some reasons why you might not be able to join. For example, if you have another serious health condition, either physical or mental, that might make it difficult or risky for you to take part. This also includes if you have a serious illness like cancer that needs active treatment, or if your doctors believe you have less than a year to live. We also can't include you if you have certain blood clotting issues, or if you've had problems with alcohol or drug use in the past year.

Also, if you have liver problems, are pregnant, or are a woman who could become pregnant and can't provide a negative pregnancy test, you wouldn't be able to participate. Finally, if you're having certain other heart devices fitted, like a CRT or ICD, or if the study doctors feel for any other reason that it wouldn't be safe or appropriate for you to join, you wouldn't be included.

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 scheduled to get a single or dual-chamber pacemaker for a heart rhythm issue?
Are you able to understand and sign consent forms?
Do you have a clear routine heart scan (echocardiogram)?
Are you not currently pregnant or planning to be?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference from a standard pacemaker procedure is that doctors will use ultrasound guidance in addition to standard methods when placing your pacemaker lead. You will undergo the usual preparations for your pacemaker implantation. During the procedure, the medical team will use ultrasound to help them see the inside of your heart more clearly while carefully positioning the pacemaker lead in the left bundle branch area. There may be some additional measurements or checks related to the ultrasound imaging during the procedure. After your pacemaker is implanted, you will have the usual follow-up appointments with your heart specialist, and there might be some extra data collected about your pacemaker's performance to help us understand how well the new technique worked. We anticipate your total involvement in the study itself would mainly be focused around your implantation procedure, with follow-up as part of your routine care.

Potential risks and benefits

Participating in this study might offer several potential benefits. It could mean your pacemaker lead is placed more accurately and with fewer attempts, potentially reducing risks associated with the procedure. It might also reduce your exposure to X-rays during the implant, which is a long-term health benefit. For the wider healthcare system, successful use of ultrasound could lead to quicker procedures and allow more people to receive pacemakers sooner. However, as with any medical procedure, there are always some risks involved, including the standard risks associated with pacemaker implantation. Because this is a research study, there's always a chance that the new technique might not work as intended in every case, or that unforeseen issues could arise, although every precaution will be taken. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

London Health Sciences Centre - University Hospital
Verified postcode
London, Canada
London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is a pacemaker?

A pacemaker is a small electronic device implanted under your skin to help control your heart rate if it's too slow or irregular.

What is the 'left bundle branch area'?

It's a specific spot deep inside your heart where the electrical signals for a strong heartbeat are sent. Placing the pacemaker lead here can often make the heart beat more naturally.

What is the difference between X-ray and ultrasound?

X-rays use radiation to take pictures through your body, while ultrasound uses safe sound waves to create live images, like a scan used during pregnancy.

Will this study affect my standard pacemaker care?

No, your medical care will be your top priority. This study is looking at a new way to place the lead, but your overall pacemaker care will remain the same as usual.

Is it safe to get less X-ray exposure?

Yes, reducing X-ray exposure is generally a good thing for long-term health, as too much radiation over time can carry risks.