Active not recruitingNAINTERVENTIONAL

From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

This study investigates the best way to treat a common irregular heartbeat called atrial fibrillation (AF) when someone experiences it suddenly and visits the emergency department. It compares two approaches: receiving the usual care, which often involves medications, versus having a special keyhole procedure called 'ablation' very early on. Researchers want to see if treating AF quickly with ablation can lead to better health outcomes, prevent the condition from getting worse, and potentially reduce hospital stays and healthcare costs. The study aims to find out if early ablation is a more effective first-line treatment for recent-onset AF.

At a glance

Status

Active not recruiting

Phase

Sponsor

Asklepios proresearch

Enrolment target

350

Start

15 Dec 2021

Estimated completion

14 Dec 2028

Atrial Fibrillation (AF)

What is this study about?

Atrial fibrillation (AF) is a very common condition where the heart beats irregularly and often quickly. Over the past 30 years, more and more people have been diagnosed with it, and it can increase the risk of other health problems like stroke. A large number of people who end up in hospital for AF first come through the emergency department. This condition, and the care it needs, costs our healthcare system a lot of money.

One effective treatment for AF is a procedure called catheter ablation. This is a keyhole procedure where doctors use special tools to create tiny scars in the heart tissue that send out the faulty electrical signals causing AF. This helps to restore a normal heart rhythm. Studies have shown that ablation is safe and can work better than just using medication to control AF, and one type of ablation, called cryoballoon ablation, might even save the NHS money.

However, doctors aren't sure about the very best time to perform ablation. Should it be done later, after other treatments have been tried, or as soon as possible after AF starts? This study aims to answer whether offering ablation straight away to patients arriving at the emergency department with new or recent-onset AF is better than the usual care. By treating AF early, doctors hope to stop it from becoming a long-term problem and improve patients' overall health.

Key takeaways

This study compares early ablation with standard care for new or recent AF.
It aims to improve treatment and reduce long-term problems caused by AF.
Participation involves being randomly assigned to a treatment group.
You'll have regular check-ups and monitoring throughout the study.
The study focuses on patients who go to A&E with recent AF.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with atrial fibrillation (AF) that started within the last year, and your AF episodes should not have lasted longer than six months. You must have recently visited an emergency department or outpatient clinic for your AF within the last two weeks, even if your heart rhythm has since gone back to normal.

You would need to be 18 years old or older and be able to understand and agree to take part in the study. There are also some conditions that would mean you couldn't join, such as if your AF has been continuous for more than six months, if you have a very enlarged heart chamber (left atrium), or if you've already had a previous heart ablation procedure.

Other reasons you might not be able to join include certain serious heart valve problems, an ongoing continuous treatment with a specific heart medication called Amiodarone, or a history of trying and failing more than one type of antiarrhythmic drug (though some common drugs like beta-blockers or taking a pill only when needed are allowed). If you have any condition that makes heart ablation or certain heart medications unsafe, or if you have certain other serious health issues like untreated thyroid problems, a history of blood clots that aren't being treated properly, or are pregnant or breastfeeding, you wouldn't be able to participate.

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 you been diagnosed with AF that started less than a year ago?
Have your AF episodes lasted less than 6 months?
Did you visit A&E or a clinic for AF in the last two weeks?
Are you 18 years old or older?
Have you not had a previous heart ablation procedure?
Are you currently not taking Amiodarone continuously?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the usual care for AF, which might involve medication, and the other group will have an early keyhole procedure called ablation. You'll have regular hospital visits for check-ups and tests, which will include heart scans and ECGs to monitor your heart rhythm and overall health. We'll track your progress carefully to see how well the treatment is working and if it affects your quality of life. The study will involve follow-up for a specific period to see the long-term effects of the treatments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving early access to an advanced treatment like ablation, which could improve your heart rhythm and overall health sooner, potentially reducing future hospital visits. However, all medical procedures, including ablation, carry some risks, such as bleeding, infection, or damage to blood vessels or the heart. You will be closely monitored, and medical staff will discuss all potential risks and benefits with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Kerckhoff-Klinik GmbH
Verified postcode
Bad Nauheim, Germany
Deutsches Herzzentrum der Charité
Verified postcode
Berlin, Germany
Herzzentrum Uniklinik Köln
Verified postcode
Cologne, Germany
Evangelisches Krankenhaus Düsseldorf
Verified postcode
Düsseldorf, Germany
Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus
Verified postcode
Frankfurt, Germany
Universitätsklinikum Giessen
Verified postcode
Giessen, Germany
Asklepios Klinik St. Georg
Verified postcode
Hamburg, Germany
Universitäres Herz- und Gefäßzentrum
Verified postcode
Hamburg, Germany
AK Altona
Verified postcode
Hamburg, Germany
AK Nord
Verified postcode
Hamburg-Nord, Germany
Asklepios Klinik Harburg
Verified postcode
Harburg, Germany
Universitätsklinikum Münster
Verified postcode
Münster, Germany

Common questions

What is Atrial Fibrillation (AF)?

Atrial fibrillation is a common condition where the heart's upper chambers beat irregularly and often too fast, which can make you feel breathless, tired, or have a fluttering sensation.

What is AF ablation?

AF ablation is a keyhole procedure where doctors create tiny scars inside your heart to block faulty electrical signals that cause the irregular heartbeat, helping your heart beat normally again.

Will I definitely get an ablation if I join?

Not necessarily. If you join, you'll be randomly assigned to one of two groups: one receives early ablation, and the other receives standard care, which might be medication-based.

How long will I be in the study?

The full duration of your participation, including follow-up visits, will be explained by the study team, but it will involve regular check-ups over a specific period.

Can I leave the study if I change my mind?

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