RecruitingOBSERVATIONAL

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up

This study is checking how well a special pacemaker wire, called the INGEVITY+ lead, works when placed in a particular area of the heart called the left bundle branch. This is for people who need a pacemaker because their heart beats too slowly or out of sync. Researchers want to see if this new approach is safe, performs well, and provides real benefits to patients over a long period. It's a 'post-market' study, meaning the device is already available, and this research helps us understand its long-term use in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

140

Start

19 Dec 2025

Estimated completion

31 Aug 2029

Bradycardia Atrioventricular Block Sinus Node Dysfunction Bundle-Branch Block

What is this study about?

You might be reading this because you or someone you know has a heart condition that causes a slow or irregular heartbeat, which often needs a pacemaker. A pacemaker is a small device placed under the skin near your collarbone that sends electrical signals to your heart to help it beat at a healthy rhythm. This can reduce symptoms like dizziness, tiredness, and shortness of breath.

This particular study is looking at a new way to place one of the pacemaker wires, called a lead. Normally, pacemaker leads might be placed in different parts of the heart to help it beat regularly. However, this study focuses on placing the lead in a very specific spot called the left bundle branch area. The idea is that stimulating the heart from this area might help it beat more naturally and effectively, leading to better long-term results for patients.

The study aims to follow patients over time to see if this method of pacing is safe, works well, and improves their health. It's an important step in understanding how best to use pacemaker technology to help people live healthier lives with heart conditions like bradycardia (slow heartbeat) and heart block (problems with electrical signals in the heart).

Key takeaways

Looks at a new way to place pacemaker wires for slow heartbeats.
Aims to understand long-term safety and effectiveness of the new method.
For people needing a new pacemaker for the first time.
Participation involves regular check-ups after receiving the pacemaker.
You can stop participating at any time.

Who may be eligible?

You might be able to take part in this study if you are at least 18 years old and your doctor has decided you need a new pacemaker for the first time. The pacemaker system your doctor plans to use must include a specific type of Boston Scientific pacemaker and the INGEVITY+ lead, which will be placed in the left bundle branch area of your heart.

Your heart condition must be one that typically requires a pacemaker. This includes having a very slow heartbeat, problems with how electrical signals travel through your heart (like second- or third-degree AV block), or certain issues with your heart's natural rhythm. You also need to be willing and able to attend all study appointments and give your informed consent, which means you understand what the study involves and agree 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 18 years old or older?
Has your doctor said you need a new pacemaker for a slow or irregular heartbeat?
Will your new pacemaker include the INGEVITY+ lead placed in the left bundle branch area?
Are you able to attend study appointments and understand what you are agreeing to?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new pacemaker system as part of your standard care. The study involves regular visits to the clinic to check how the pacemaker is working and how you are feeling. These visits will happen at specific times after your pacemaker is put in place, allowing the medical team to gather information about your health and the pacemaker's performance over time. The exact number and timing of visits will be explained to you by the study team, but they are designed to monitor your progress and the pacemaker's safety and effectiveness.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new pacing technique that could potentially lead to better heart function and quality of life for people with slow heartbeats. However, as with any medical procedure, there are potential risks associated with getting a pacemaker, although these are generally low. These can include risks related to the procedure itself, or problems with the device over time. All these risks will be fully explained by the study team before you decide to take part. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (13)

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

St. Jan-Hospital
Verified postcode
Bruges, Belgium· Recruiting
Clinique Saint-Pierre Ottignies-Hospital
Verified postcode
Brussels, Belgium· Recruiting
CHRU de Lille
Verified postcode
Lille, France· Recruiting
Hospital Europeen Georges-Pompidou (HEGP)
Verified postcode
Paris, France· Recruiting
Marienhospital-Hospital
Verified postcode
Osnabrück, Germany· Not yet recruiting
Saarland University Hospital
Verified postcode
Homburg, Germany· Not yet recruiting
Azienda Ospedaliero-Universitaria di Ferrara-Hospital
Verified postcode
Ferrara, Italy· Not yet recruiting
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Verified postcode
Milan, Italy· Not yet recruiting
AOU Maggiore
Verified postcode
Novara, Italy· Recruiting
Virgen de las Nieves University Hospital
Verified postcode
Granada, Spain· Recruiting
Hospital Clinico Universitario Lozano Blesa
Verified postcode
Zaragoza, Spain· Recruiting
Inselspital Bern
Verified postcode
Bern, Switzerland· Not yet recruiting

Common questions

What is a pacemaker?

A pacemaker is a small electronic device implanted in your chest to help your heart beat regularly if it's too slow or irregular.

What is 'left bundle branch area pacing'?

It's a new technique where the pacemaker wire is placed in a specific part of your heart called the left bundle branch area, which might help your heart beat more naturally.

Why is this study being done?

This study wants to learn more about how safe and effective this new pacing technique is for patients over a long period after they've received the pacemaker.

Will I get special treatment in the study?

You will receive the pacemaker as part of your standard medical care, but your health and the pacemaker's performance will be monitored closely as part of the study.

What if I change my mind about participating?

You can decide to leave the study at any time, and this will not affect the medical care you receive.

How to find out more

Jens Goetzke, Dipl.-Ing. (FH)

septa_pmcf@bsci.com 800-227-3422 Official trial record

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