RecruitingOBSERVATIONAL

Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

This study, called NORMAND'HIS / STIMU'HIS, is a national project looking at the long-term effects of a special type of pacemaker called conduction system pacing (CSP). Doctors want to find out how well these pacemakers keep working over time, checking the heart's electrical signals, how the heart muscle functions, and the overall health of patients. Currently, there isn't much information about the very long-term benefits of CSP. This study hopes to collect detailed information for at least two years to understand if these pacemakers continue to deliver electrical signals effectively and prevent problems like an enlarged heart or an irregular heartbeat (atrial fibrillation). The findings will help doctors better understand the advantages of CSP compared to more traditional pacemakers.

At a glance

Status

Recruiting

Sponsor

University Hospital, Rouen

Enrolment target

2,500

Start

01 Mar 2023

Estimated completion

31 Mar 2028

Conduction System Pacing

What is this study about?

You might be familiar with pacemakers, which are small devices placed in the chest to help the heart beat regularly. This study is focusing on a newer, special type called "conduction system pacing" (CSP). Instead of just zapping the heart muscle, CSP tries to work with the heart's natural electrical wiring. Think of it like a new way to send electrical messages to your heart.

The main idea behind this study is to closely watch people who have had this special type of pacemaker fitted. Doctors want to see how well it works over several years. This includes checking the electrical signals from the pacemaker, how efficiently your heart muscle is pumping blood (using scans called echocardiograms), and your general health, like whether you get breathless or need to go to the hospital. There's a lot we don't know about how this newer pacing method performs in the long run, and this study aims to fill those gaps in our knowledge.

By gathering lots of detailed information from many patients, this study hopes to show if conduction system pacing truly offers lasting benefits. For example, they'll check if it helps prevent problems that can sometimes happen with older pacemaker types, like the heart muscle getting stretched out or dealing with irregular heartbeats. This research is really important because it could help doctors decide if this special pacemaker is the best option for many more people in the future.

Key takeaways

This study evaluates a special pacemaker type called Conduction System Pacing (CSP).
It aims to understand CSP's long-term effects on heart health and electrical signals.
Data will be collected during your standard pacemaker check-ups, no extra visits.
It will help doctors decide if CSP is a better long-term option for patients.
Your general health and heart function will be regularly monitored.
The study lasts for at least two years.

Who may be eligible?

To be part of this study, you must have already had an attempt to fit a conduction system pacemaker. You also need to be 18 years old or older. It's important that you understand what the study is about and are willing to give your permission to take part.

There are some reasons why you wouldn't be able to join. For example, if you are currently under legal guardianship or protection, or if you are pregnant, breastfeeding, or could become pregnant and aren't using effective contraception. If you've been through menopause, the study team would need to confirm that medically.

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.

Have I already had an attempt to fit a special pacemaker called conduction system pacing?
Am I 18 years old or older?
Do I understand what the study is about?
Am I willing to give my permission to take part?
Am I not pregnant or breastfeeding, and if I could get pregnant, am I using reliable contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new treatments or medications. Instead, the study will simply involve collecting information during your regular follow-up appointments for your pacemaker. This means your doctors will continue to check your pacemaker and your heart as they normally would.

During these routine visits, the study team will specifically record details about your pacemaker's performance, such as how much energy it uses and how it sends electrical signals. They will also keep track of your heart's health using scans called echocardiograms, which look at how well your heart muscle is pumping. Additionally, they will note down any hospital stays for heart-related issues and how you feel in terms of your energy levels and breathlessness. This will happen over a period of at least two years, so the doctors can see how things change over time.

Potential risks and benefits

Participating in this study mainly involves allowing your doctors to collect extra information from your routine pacemaker check-ups. There are no new treatments or procedures involved, which means there are generally no extra risks to your health by just being part of the observation. The potential benefit is that your information, combined with that of many other patients, will help doctors learn more about how this special pacing method works in the long term, potentially leading to better care for you and others in the future. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (10)

CHU Caen
Verified postcode
Caen, France· Recruiting
CHI Elbeuf
Verified postcode
Elbeuf, France· Recruiting
Groupe Hospitalier La Rochelle Ré-Aunis
Verified postcode
La Rochelle, France· Recruiting
CH Le Havre
Verified postcode
Le Havre, France· Recruiting
CHU Lille
Verified postcode
Lille, France· Recruiting
Hôpital Saint Philibert
Verified postcode
Lomme, France· Recruiting
CHU Rennes
Verified postcode
Rennes, France· Recruiting
Rouen University Hospital
Verified postcode
Rouen, France· Recruiting
Clinique Saint Hilaire
Verified postcode
Rouen, France· Recruiting
CHU Sud Réunion
Verified postcode
Saint-Pierre, France· Recruiting

Common questions

What is 'conduction system pacing'?

It's a newer type of pacemaker that tries to work more closely with your heart's natural electrical wiring, rather than just delivering a general electrical pulse.

What kind of information will be collected?

Doctors will gather details from your regular pacemaker check-ups, including how well your pacemaker is working, results from heart scans (echocardiograms), and information about your general health.

Will I have any extra hospital visits for this study?

No, the study will collect information during your routine pacemaker follow-up appointments, so you won't need to make any extra trips just for the study.

How long will I be in the study?

The study aims to follow patients and collect information for at least two years to understand the long-term effects of this pacing method.

Can I stop being part of the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your medical care in any way.

How to find out more

Corentin Chaumont, MD

corentin.chaumont@chu-rouen.fr + 33637182032 Official trial record

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