Not yet recruitingPHASE3INTERVENTIONAL

Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device

This research is looking at better ways to put in heart devices like pacemakers and defibrillators. These devices are becoming more common in the UK to help people's hearts beat correctly. The study compares three different techniques for inserting the tiny wires (called 'leads') that go from the device into the heart. These techniques involve using different veins near the shoulder or neck. The main aim is to find out which method is the safest, causes the fewest problems, and is easiest for doctors to perform. This is a very important step to improve a common heart procedure for many patients.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Hospices Civils de Lyon

Enrolment target

900

Start

01 Sep 2026

Estimated completion

01 Feb 2028

Primary Implantation of an Intracardiac Electronic Device Indication

What is this study about?

When someone needs a pacemaker or a defibrillator, doctors need to put small wires into the heart through a vein. These wires connect to a small device, often placed under the skin near the shoulder. Think of it like a delicate electrical system for your heart. This procedure is very common and helps many people with heart conditions.

There are several ways doctors can access the vein to insert these wires. Each method has its own benefits and challenges. This study specifically compares three main approaches: one where doctors carefully cut down to expose a vein in the arm (cephalic vein dissection), and two newer methods that use ultrasound scans to guide a needle into a vein near the armpit (axillary route). The ultrasound guidance helps doctors see exactly where they are going, which can make the process smoother and safer.

The main goal of this research is to see which of these three methods is the most effective and safest for patients. They want to find out which one works best, causes the fewest complications like bruising or nerve issues, and how long each procedure takes. By comparing these techniques, doctors hope to improve how these essential heart devices are put in, making the experience better and safer for thousands of patients who need them.

Key takeaways

Compares three ways to implant pacemakers/defibrillators.
Aims for safer and better implantation methods.
Uses ultrasound guidance for some techniques.
Participation involves random assignment to a method.
Follow-up will monitor device and recovery.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must be getting a pacemaker or defibrillator for the very first time. If you need a new lead (wire) for a specific heart area, you might also be able to join.

There are some reasons why you wouldn't be able to take part. For example, if you are pregnant, breastfeeding, or if you already have a very complex type of heart device. Also, if you've previously had problems with accessing a vein for a similar procedure, you might not be eligible. They're also excluding people who are involved in other research that might affect the results of this study.

The researchers want to make sure the study focuses on specific groups to get clear results. This means they can't include everyone, but it helps them find the best way to improve care for a lot of people.

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?
Is this your first time getting a pacemaker or defibrillator?
Are you currently pregnant or breastfeeding?
Have you had trouble accessing a vein for a medical procedure before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing is that your doctor will use one of the three different ways to put in your pacemaker or defibrillator. Which method is used will be decided randomly, like flipping a coin. You won't have a choice in which method you receive. The procedure itself will be like a standard operation where you'll be monitored closely.

After your procedure, you'll have follow-up appointments, just like anyone getting a pacemaker or defibrillator. These appointments will check how well the device is working and how you are recovering. The research team will specifically gather information on how the procedure went, if there were any issues, and how quickly you recover. The total duration of your participation will cover your procedure and the usual follow-up checks, which can vary but typically involve appointments over several months to a year.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping doctors find the safest and most effective way to implant heart devices in the future, ultimately improving care for other patients. However, you might not directly benefit yourself. All medical procedures carry some risks, and while every care will be taken, potential risks associated with the different implantation methods include bruising, bleeding, or, in rare cases, more serious issues like lung problems or nerve damage. These are possible complications with any pacemaker or defibrillator implantation, regardless of the study. You always have the right to withdraw from the study at any time without giving a reason, and this will not affect your standard medical care.

Locations (7)

CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France
Hôpital F. MITTERRAND
Verified postcode
Dijon, France
Lyon-Croix Rousse
Verified postcode
Lyon, France
Lyon-Louis Pradel
Verified postcode
Lyon, France
Hôpital privé Jacques Cartier
Verified postcode
Massy, France
CH Annexy-Genevois, site Annecy
Verified postcode
Metz, France
CHU de Saint Etienne - Hôpital Nord
Verified postcode
Saint-Priest-en-Jarez, France

Common questions

What is a pacemaker or defibrillator?

These are small devices put into your body to help your heart beat regularly or to deliver a shock if your heart rhythm becomes dangerous.

Why are different methods being compared?

Doctors want to find out which way of putting in these devices is the safest, quickest, and causes the fewest problems for patients.

Will I get to choose which method is used for my procedure?

No, if you join the study, the method will be chosen randomly, like by chance, to ensure fair comparison.

What kind of follow-up will I have?

You'll have regular check-ups after your procedure, just like any patient with one of these devices, to make sure it's working well.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical care.

How to find out more

Paul CHARLES, Dr

paul.charles@chu-lyon.fr 04 72 07 16 72 Official trial record

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