Not yet recruitingOBSERVATIONAL

Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing

This study is investigating a new type of pacemaker lead for people who need a special heart treatment called Cardiac Resynchronization Therapy (CRT). This new lead, called an LBBAP ICD lead, is smaller and might reduce the number of leads needed. Doctors hope this could mean fewer problems during and after the procedure. The study will enrol patients who already need CRT and will try to implant this new lead. It will check how well the treatment works, how safe the leads are, and how easy they are for doctors to implant. The goal is to see if this new approach is a good option compared to current treatments.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Caen

Enrolment target

200

Start

01 May 2026

Estimated completion

01 Sep 2027

Cardiac Resynchronization Therapy Left Bundle Branch Area Pacing

What is this study about?

Imagine your heart is a band, and sometimes the instruments (the different parts of your heart) don't play in time, making it less efficient at pumping blood. This is what happens in some types of heart failure. Cardiac Resynchronization Therapy, or CRT, is like a conductor helping the heart's instruments play in harmony again, using a special type of pacemaker.

Traditionally, CRT might involve several wires (called leads) placed in different parts of your heart. This study is looking at a new, smaller type of lead called an LBBAP ICD lead. Doctors think this new lead might be able to do the same job as multiple leads, but with potentially less surgery and fewer long-term issues. If successful, this could be a simpler, safer way to give people the CRT treatment they need.

This study, called FORGE CSP, is trying to find out how well this new LBBAP ICD lead works in real patients who need CRT. It will track how many patients benefit from it, how easy it is for doctors to implant, and if there are any new or fewer side effects compared to the older methods. They will also look at the costs and how patients feel after the procedure. This will help doctors understand if this new heart treatment is better for patients needing CRT.

Key takeaways

Investigating a new, smaller pacemaker lead for heart failure patients.
Aims to make Cardiac Resynchronization Therapy (CRT) potentially simpler and safer.
Will track success rate, safety, and ease of implantation of the new lead.
No extra treatments; data collected during your regular medical care.
Could help shape future CRT guidelines for heart patients.

Who may be eligible?

To be part of this study, you need to be an adult over 18 years old. Also, your doctor must have already decided that you need a specific type of heart treatment called Cardiac Resynchronization Therapy (CRT) based on current expert guidelines.

Importantly, for this study, the doctors must attempt to use this new LBBAP ICD lead as the very first option for your treatment. You also need to have national health insurance coverage to participate.

It's important to note that if you are pregnant, you won't be able to join this study. Other specific medical conditions will also be checked by the study doctors to make sure it's safe for you to take part.

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 over 18 years old?
Has your doctor already told you that you need Cardiac Resynchronization Therapy (CRT)?
Is your doctor considering using a new LBBAP ICD lead as the first attempt for your treatment?
Do you have national health insurance coverage in the UK?
Are you currently not pregnant?

Answer every question to see your result.

What does participation involve?

This study is a registry, which means it will collect information about your treatment if your doctor decides to use the new LBBAP ICD lead for your Cardiac Resynchronization Therapy (CRT). You won't be given any experimental medication, but rather undergo the procedure as planned by your medical team.

Taking part involves having the LBBAP ICD lead implanted. After the procedure, the study will collect information about how you're doing, the success of the lead placement, and any check-ups you have. This will happen during your normal follow-up appointments with your heart doctor. The total duration of your participation will depend on the normal follow-up schedule for your pacemaker, and you won't need extra visits just for the study.

Potential risks and benefits

The potential benefit of taking part is that you might receive an innovative approach to your Cardiac Resynchronization Therapy (CRT) that could lead to fewer complications or a simpler procedure compared to standard methods. However, as with any medical procedure, there are potential risks, such as issues during the implantation procedure, the lead moving out of place, or effects on other heart valves. These will be carefully monitored. You always have the right to withdraw from providing your data for the study at any time without it affecting your medical care.

Locations (1)

Caen University Hospital
Verified postcode
Caen, France

Common questions

What is Cardiac Resynchronization Therapy (CRT)?

CRT is a special type of pacemaker treatment for some people with heart failure, helping the heart's chambers beat together more effectively.

What is an LBBAP ICD lead?

It's a new, smaller pacemaker wire (lead) designed to deliver CRT. Doctors hope it can simplify the procedure and reduce risks.

Will I get extra medical care if I join this study?

You will receive the CRT treatment your doctor recommends. This study primarily collects information about your treatment and progress during your standard care, so there are no extra medical treatments involved.

What are the main goals of this study?

The study aims to see how well this new LBBAP ICD lead works for CRT, how safe it is, and how easy it is for doctors to implant.

Can I leave the study if I change my mind?

Yes, you can decide to stop your information from being used in the study at any time, and it won't affect your medical care.

How to find out more

Pierre OLLITRAULT, MD

ollitrault-p@chu-caen.fr +330231063106 Official trial record

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