RecruitingNAINTERVENTIONAL

Improving CRT Outcome With Non-Invasive Cardiac Mapping

This study is investigating a new approach to placing a cardiac resynchronisation therapy (CRT) device for patients with heart failure. We're comparing the usual way of placing the device with a new method that uses a special mapping system called Amycard 01C. This system helps doctors identify the best spot in the heart for the device lead. The main goal is to see if using this mapping system leads to better outcomes for patients, by significantly improving how the heart pumps blood compared to the standard approach. European hospitals are taking part, and we expect to include around 330 patients in total.

At a glance

Status

Recruiting

Phase

Sponsor

EP Solutions SA

Enrolment target

330

Start

20 Dec 2023

Estimated completion

01 Dec 2027

Heart Failure With Reduced Ejection Fraction

What is this study about?

This research study is looking into ways to improve treatment for people living with a type of heart failure called 'heart failure with reduced ejection fraction'. This means your heart muscle isn't pumping blood as effectively as it should. One common treatment is a device called Cardiac Resynchronisation Therapy (CRT), which is like a special pacemaker that helps the heart's pumping chambers (ventricles) beat in a more organised way. This study is testing if using a special mapping system, called the Amycard 01C, before placing the CRT device can help doctors choose the very best spot in your heart for one of the device's wires. This precise placement might make the CRT device work even better.

Currently, doctors have standard ways of deciding where to put this wire. This study wants to see if using the Amycard 01C mapping system to find the heart's 'Latest Electrical Activated Site' (LEAS) can improve the success of CRT. An improved outcome means your heart pumps blood more effectively after the device is put in. We'll be comparing patients who have their device placed using the standard method with those whose doctors use the Amycard 01C system to guide the placement.

This study is being conducted in hospitals across Europe and aims to provide stronger evidence that this new mapping device can genuinely make a difference for patients receiving CRT. By finding the optimal placement for the CRT device lead, we hope to help more people with heart failure feel better and improve their heart’s function.

Key takeaways

This study evaluates a new way to place heart devices for heart failure.
It compares standard placement with guidance from the Amycard 01C mapping system.
The aim is to improve how well the heart device works for patients.
Participation involves monitoring your heart's health after device implantation.
The study is for adults aged 18 and over with specific types of heart failure.

Who may be eligible?

This study is designed for adults aged 18 and over who have heart failure with reduced ejection fraction and are already considering getting a CRT device. You would need to have been on the best possible medication for your heart failure for at least three months.

To be considered, you also need to meet certain heart rhythm criteria, specifically those recommended by European guidelines for CRT. Importantly, you shouldn't have had a pacemaker or similar heart device implanted before, and you can't have certain medical conditions or be pregnant (or planning to become pregnant within six months).

There are also a few practical checks, like not having an ongoing skin condition on your chest that would prevent applying special monitoring patches for the mapping system, and not having any reasons why you couldn't have a CT scan.

Quick self-check

Are you 18 years old or older?
Do you have heart failure and are you considering a CRT device?
Have you been on regular heart failure medication for at least 3 months?
Do you have no previous pacemaker or similar heart device?
Are you not pregnant or planning to become pregnant in the next 6 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your journey would involve either receiving your CRT device with the usual placement methods or with the guidance of the new Amycard 01C mapping system. The study doesn't involve any extra medication; it's focused on how the device is placed. You would have planned study visits, likely at several points after your device is implanted, to check on your heart's function and how you're feeling. These assessments will help us understand if the new method is making a difference. The exact number and timing of visits will be explained by the study team, but they will be spread out over a period to monitor your progress.

Potential risks and benefits

Participating in any clinical study has potential benefits and risks. You might benefit if the new mapping technique leads to a more effective CRT device placement, improving your heart function and well-being. However, there's no guarantee, and the standard placement method is also very effective. Potential risks are generally associated with the CRT implantation procedure itself, as well as specific procedures for this study, such as undergoing a CT scan or having body surface mapping. These would be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (11)

Amsterdam University Medical Center
Amsterdam, Netherlands· Not yet recruiting
Groningen University Medical Center
Groningen, Netherlands· Not yet recruiting
Leids Universitair Medical Center
Leiden, Netherlands· Not yet recruiting
Maastricht University Hospital
Maastricht, Netherlands· Recruiting
Utrecht University Medical Center
Utrecht, Netherlands· Not yet recruiting
Hospital da Luz
Lisbon, Portugal· Not yet recruiting
Lund University Hospital
Lund, Sweden· Not yet recruiting
Karolinska University Hospital
Stockholm, Sweden· Not yet recruiting
Bart's Hospital
London, United Kingdom· Not yet recruiting
King's College
London, United Kingdom· Not yet recruiting
Oxford University Hospital
Oxford, United Kingdom· Not yet recruiting

Common questions

What is heart failure with reduced ejection fraction?

It's a type of heart failure where your heart muscle struggles to pump enough blood out to your body with each beat.

What is a CRT device?

It's a small device implanted in your chest, similar to a pacemaker, that helps your heart's pumping chambers beat in a more coordinated way.

What does 'non-invasive cardiac mapping' mean?

It's a way to map the electrical activity of your heart from outside your body, without needing to go inside with instruments.

Will I know which treatment group I'm in?

This is a randomised study, meaning participants are randomly assigned to a group (standard care or new mapping technique). You will be informed by the study team.

How long will the study last for me?

The study collects information over a period of time after your device is implanted. The study team will inform you about the specific follow-up appointments.

How to find out more

Matthias Egger, PhD

matthias.egger@ep-solutions.ch +41 78 659 22 75 Official trial record

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