RecruitingNAINTERVENTIONAL

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

The EASThigh-AFNET 11 study is looking into whether an early procedure called atrial fibrillation 'ablation' can help patients with an irregular heartbeat (atrial fibrillation) and other long-term health conditions. The aim is to see if ablation is better than usual care at preventing serious events like strokes, heart failure, or even death related to heart problems. Many people with atrial fibrillation, especially older individuals or those with other health issues, can still face these complications, even when receiving the best current treatments. This study compares ablation, which helps keep the heart rhythm steady, against the standard care to find out if it's a safer and more effective option for these patients.

At a glance

Status

Recruiting

Phase

Sponsor

Atrial Fibrillation Network

Enrolment target

2,312

Start

14 Oct 2024

Estimated completion

01 May 2030

Atrial Fibrillation

What is this study about?

This study, called EASThigh-AFNET 11, is looking at a common heart condition known as atrial fibrillation, or AF. AF causes your heart to beat with an irregular and often fast rhythm. While there are good treatments for AF, some people, especially those with other health problems, can still be at risk of serious issues like strokes, heart failure, or heart-related deaths. The study wants to discover if an early procedure called 'ablation' can help prevent these problems more effectively than the standard care we currently provide.

Atrial fibrillation can make you feel unwell, but more importantly, it can lead to dangerous complications. Doctors already know that trying to control the heart's rhythm early on can help reduce these risks. Traditionally, this has often been done with medications. However, this study is exploring a procedure called ablation. Ablation involves using heat or cold energy to create tiny scars in the heart that block the faulty electrical signals causing the irregular heartbeat. The idea is that ablation might be better at keeping the heart rhythm steady and could avoid the need for long-term medications.

The researchers believe that ablation could be a very good option for patients with AF who also have other significant health conditions. This study aims to provide clear answers on whether this procedure is a safe and effective way to protect these patients from serious heart-related problems.

Key takeaways

This study compares an early heart procedure (ablation) with standard care for irregular heartbeats.
It focuses on patients with atrial fibrillation who also have other significant health problems.
The main goal is to see if ablation can prevent strokes, heart failure, or heart-related deaths more effectively.
Participation means being randomly assigned to one of two treatment groups.
Both treatments used in the study are already approved by doctors.

Who may be eligible?

To join this study, you would need to have been diagnosed with an irregular heartbeat (atrial fibrillation) for the first time within the last five years and have proof of this from an ECG test. You also need to have several other health conditions that place you at a higher risk, according to a score doctors use called the CHA2DS2-VASc score (specifically, a score of 4 or higher).

You must be at least 18 years old and suitable for the ablation procedure, as decided by the study doctors. Before taking part, you'll need to understand the study fully and give your written permission (informed consent).

There are also some reasons why you couldn't join. For example, if you have a serious illness that means you're not expected to live more than a year, or if you're taking part in another clinical trial at the same time. You also couldn't join if you've had an AF ablation before, had a stroke very recently (within the last 3 months), or if you are pregnant or breastfeeding. Other specific heart problems or uncontrolled thyroid issues would also prevent you from being eligible.

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 been diagnosed with an irregular heartbeat (atrial fibrillation) within the last 5 years?
Do I have a few other health conditions that make my health risks higher?
Am I at least 18 years old?
Have I never had an AF ablation procedure before?
Am I not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to either receive early atrial fibrillation ablation or to continue with your usual medical care for your heart condition. This means you might get the ablation procedure, or you might continue with medications and other treatments your doctor thinks are best for you. Both approaches use treatments that are already approved by medical authorities.

Throughout the study, the doctors and nurses will regularly check on your health and any heart-related events like strokes, heart failure, or other serious problems. They will also look at how you feel and your thinking abilities. The study will continue until a certain number of these serious events have occurred across all participants. There is no set total duration, but you will have follow-up appointments and assessments as planned by the study team.

Potential risks and benefits

Taking part in this study could offer several potential benefits. If you are in the ablation group, you might find that your heart rhythm is better controlled, potentially leading to fewer serious heart-related problems like stroke or heart failure. For those in the usual care group, you will continue to receive the best standard treatment for your condition. However, there are also potential risks with any medical procedure or treatment. Ablation, like any surgery, carries some risks, which your doctor will explain fully. Also, it's possible that the treatment approach you receive might not work as well as hoped for you personally. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Several sites
Unverified
Multiple Locations, Australia· Not yet recruiting
Several sites
Unverified
Multiple Locations, Canada· Recruiting
Several sites
Unverified
Multiple Locations, Germany· Recruiting
Several sites
Unverified
Multiple Locations, Netherlands· Recruiting
Several sites
Unverified
Multiple Locations, Poland· Recruiting
Several sites
Unverified
Multiple Locations, Spain· Recruiting
Several sites
Unverified
Multiple Locations, United Kingdom· Not yet recruiting

Common questions

What is atrial fibrillation?

It's an irregular and often rapid heartbeat that can increase your risk of stroke, heart failure, and other heart-related complications.

What is ablation?

It's a procedure where doctors use special tools to create small scars in your heart to block faulty electrical signals causing an irregular heartbeat.

What is 'usual care'?

This refers to the standard medical treatments and approaches currently recommended by doctors for managing atrial fibrillation.

Will I definitely get ablation if I join?

No, you will be randomly assigned to either receive early ablation or continue with usual medical care. It's like flipping a coin for treatment groups.

What does 'high comorbidity burden' mean?

It means you have atrial fibrillation along with several other health conditions that increase your overall health risks, as assessed by your doctor.

How to find out more

Antje Albring, Dr.

easthigh@af-net.eu +49 251 980 1330 Official trial record

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