RecruitingNAINTERVENTIONAL

Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

This study is testing a new, more personalized way to treat atrial fibrillation (AF), which is a common type of irregular heartbeat. It uses a special non-invasive mapping system to create a detailed picture of the heart and identify specific areas causing the AF. This helps doctors guide a procedure called ablation, where tiny scars are made to block the faulty electrical signals. Researchers want to find out if this personalized ablation treatment is better at stopping AF straight away and preventing it from returning, compared to the usual treatment. This is a pilot study, meaning it's an early look to see if this new approach is practical and safe for patients.

At a glance

Status

Recruiting

Phase

Sponsor

German Heart Institute

Enrolment target

Start

15 Jan 2026

Estimated completion

31 Dec 2027

Atrial Fibrillation (AF)

What is this study about?

This study is for people who have a type of irregular heartbeat called atrial fibrillation (AF) that is persistent. This means their heart stays in an irregular rhythm most of the time. The usual treatment for AF in some cases is a procedure called catheter ablation, where doctors try to block the faulty electrical signals in the heart that cause the AF. Often, this starts by treating a specific area around the 'pulmonary veins' in the heart.

However, for some people, this standard approach might not be enough. This study is exploring a new, more tailored way to guide the ablation procedure. It uses a special technology called 'non-invasive global mapping' to get a very detailed picture of the heart from outside the body. This map helps doctors find the exact spots that are causing the AF in each individual patient. The idea is that by targeting these specific areas, the treatment will be more effective.

The main goals of this study are to see if using this personalized mapping system helps stop AF during the ablation procedure itself, and if it reduces the chance of AF coming back later on. Researchers will compare this new, personalized method to the standard treatment to understand which works better. They also want to make sure the new approach is safe and practical for patients.

Key takeaways

This study tests a new way to treat persistent atrial fibrillation.
It uses a special 'non-invasive' map to guide personalized heart ablation.
The goal is to stop AF more effectively and prevent it from returning.
It compares the new method to standard treatment.
You'll have clinic and phone follow-ups for two years.

Who may be eligible?

This study is looking for adults aged 18 or older who have persistent atrial fibrillation (AF) and are planning to have a catheter ablation procedure for the first time. To be included, you would also need to have some enlargement of the left side of your heart, which can be measured in different ways by your doctor.

However, certain health conditions or past treatments would mean you couldn't take part. For example, if you've already had a heart ablation procedure in the past, or if you've had a stroke or mini-stroke (TIA). The study also can't include pregnant or breastfeeding individuals, or anyone with severe heart failure or serious kidney problems.

Additionally, if you have certain skin conditions or allergies that might cause problems with skin irritation from the equipment used, you wouldn't be able to join. Your doctor will carefully check all these points to see if this study is suitable for you.

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.

I am 18 years old or older.
I have persistent atrial fibrillation.
I have never had a heart ablation before.
My doctor has told me I have some enlargement of the left side of my heart.
I have not had a stroke or mini-stroke in the past.
I am not pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo a catheter ablation procedure. This procedure will use both the new non-invasive global mapping system, which helps identify specific areas in your heart to treat, and the standard system doctors already use. Everyone in the study will first have the usual treatment around the pulmonary veins, and then receive additional personalized treatment to up to three other areas based on the new mapping system.

After your ablation, you will have several follow-up appointments. You'll need to visit the clinic three times: at 3 months, 6 months, and 12 months after your procedure. You will also have two telephone calls for follow-up, one at 9 months and another at 24 months after your ablation. The total duration of your participation in the study, including follow-up, will be about two years.

Potential risks and benefits

This study offers the potential benefit of a more personalized and potentially more effective treatment for your atrial fibrillation, which could reduce the chance of your AF returning. However, as with any medical procedure, there are potential risks associated with catheter ablation, which your doctor will explain in detail. This is a pilot study, so while it aims to be safe, there's always a chance of unexpected effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

German Heart Center of the Charité, Charité University Hospital Berlin
Verified postcode
Berlin, Germany· Recruiting
Frankfurt University Heart and Vascular Center
Verified postcode
Frankfurt am Main, Germany· Not yet recruiting
Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta
Verified postcode
Lisbon, Portugal· Not yet recruiting
Hospital Clinic, University of Barcelona
Verified postcode
Barcelona, Spain· Not yet recruiting
Gregorio Marañón General University Hospital
Verified postcode
Madrid, Spain· Not yet recruiting

Common questions

What is 'atrial fibrillation'?

Atrial fibrillation (AF) is a common heart condition that causes an irregular and often abnormally fast heart rate.

What is 'ablation'?

Ablation is a procedure where doctors use heat or cold to create tiny scars in the heart, blocking faulty electrical signals that cause irregular heartbeats.

What does 'non-invasive global mapping' mean?

It's a way to get a detailed picture of your heart's electrical activity from outside your body, without needing to put anything inside.

Why is this study 'personalized'?

It aims to tailor the ablation treatment to your specific heart, targeting the precise areas that cause your AF, rather than just using a standard approach.

How long will the study last for me?

Your participation, including follow-up appointments, will last for about two years after your ablation procedure.

How to find out more

Till F Althoff, M.D.

till.althoff@dhzc-charite.de 0049 30 450613163 Official trial record

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