Active not recruitingNAINTERVENTIONAL

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

This study looks at different ways to treat a common heart rhythm problem called persistent atrial fibrillation (AF). If you have persistent AF, your heart beats irregularly for longer periods. Doctors use a procedure called catheter ablation to fix this. This study compares three slightly different methods of ablation: one that focuses on a specific area around the lung veins, another that adds treating 'driver' areas, and a third that adds treating the back wall of the heart. The goal is to see which of these refined techniques is most effective at returning your heart to a normal rhythm and keeping it there, ultimately improving your quality of life.

At a glance

Status

Active not recruiting

Phase

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

617

Start

01 Jun 2021

Estimated completion

01 Dec 2027

Atrial Fibrillation

What is this study about?

This research study is looking into better ways to treat a persistent type of irregular heartbeat called atrial fibrillation (AF). In AF, the upper chambers of your heart (atria) beat chaotically, which can make you feel tired, breathless, or have chest pain. For some people, medicines don't control their AF well enough, and doctors might suggest a procedure called catheter ablation.

Catheter ablation is a keyhole procedure where doctors use thin, flexible wires (catheters) to create small scars in your heart. These scars block the faulty electrical signals that cause AF, helping your heart beat steadily again. This study focuses on people with persistent AF, meaning their irregular heartbeat lasts for more than three months.

The study aims to compare three slightly different approaches to catheter ablation. All three methods start by treating an area around the pulmonary veins (the veins that bring blood from your lungs to your heart), which is a common source of AF. The second approach also targets other 'driver' areas that seem to keep the AF going. The third approach adds treatment to the back wall of the heart. By comparing these techniques, doctors hope to find out which one is most effective at stopping persistent AF from coming back.

Key takeaways

Compares three different ways to perform catheter ablation for persistent AF.
Aims to find the most effective ablation strategy for lasting relief from AF.
Uses modern ablation technology for all participants.
Participation involves either one of the three specific ablation methods.
Designed for people whose AF medication hasn't worked well.
You will be randomly assigned to one of the three treatment groups.

Who may be eligible?

To join this study, you need to be at least 18 years old and have persistent atrial fibrillation. This means your AF has been ongoing for more than 3 months but less than 3 years. You should have symptoms from your AF, like feeling palpitations or breathless, and have tried at least one medication that didn't work well enough. This would be your first ablation procedure for AF.

There are also some reasons why you might not be able to join. For instance, if your AF only lasts for short periods (paroxysmal AF) or if it's been going on for a very long time (more than 3 years). You also can't join if your AF is due to a clear, reversible cause, or if you have certain other heart problems, like a very enlarged left atrium. Being pregnant would also prevent you from participating. This study is for people who are actively trying to get their heart back into a normal rhythm.

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.

Are you 18 years old or older?
Is this your first time having a heart ablation procedure for AF?
Has your AF usually lasted for more than 3 months but less than 3 years?
Do you get symptoms from your AF (like feeling tired, breathless, or heart fluttering)?
Have you tried AF medication that didn't fully control your symptoms?
Have you had your AF officially recorded by an ECG or monitor in the last 2 years?

Answer every question to see your result.

What does participation involve?

If you choose to take part, you would have an ablation procedure for your atrial fibrillation. You would be randomly assigned to one of the three different ablation methods being studied. This means neither you nor your doctor would choose which method you receive; it's decided by chance, like flipping a coin. All methods use modern techniques to ensure the most effective and safe procedure possible. You would have follow-up appointments to check on your heart rhythm and overall health to see how well the ablation worked. The total duration of your involvement in the study would depend on the follow-up schedule established by the research team.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a cutting-edge ablation technique that could be more effective for your persistent atrial fibrillation. However, as with any medical procedure, there are potential risks associated with catheter ablation, which your doctor will explain in detail. These risks are generally low but can include bruising, bleeding, or, rarely, more serious complications. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (32)

Brigham & Women'S Hosptial Inc.
Verified postcode
Boston, United States
Canberra Heart Rhythm Foundation
Verified postcode
Garran, Australia
Royal Adelaide Hospital and Cardiovascular Centre
Verified postcode
Adelaide, Australia
Alfred Health
Verified postcode
Melbourne, Australia
Royal Melbourne Hospital
Verified postcode
Parkville, Australia
Medical University of Graz
Verified postcode
Graz, Austria
Ordensklinikum Linz GmbH
Verified postcode
Linz, Austria
OLV Hospital Aalst
Verified postcode
Aalst, Belgium
Antwerp University Hospital (UZA)
Verified postcode
Edegem, Belgium
AZ Sint-Jan
Verified postcode
Ruddershove, Belgium
University of Calgary Foothills
Verified postcode
Calgary, Canada
Vancouver General Hospital
Verified postcode
Vancouver, Canada

Common questions

What is 'atrial fibrillation'?

It's an irregular and often fast heartbeat, where the top chambers of your heart beat out of sync with the bottom chambers.

What does 'catheter ablation' mean?

It's a procedure where doctors use thin wires to create tiny scars in your heart to block faulty electrical signals causing the irregular beat.

Why are there three different ways of doing the ablation in this study?

Doctors want to compare slightly different techniques to find out which one works best for persistent atrial fibrillation.

Will I know which treatment I'm getting?

No, you will be assigned to one of the three treatments by chance, like drawing lots, to make the comparison fair.

What is 'persistent AF'?

This means your irregular heartbeat often lasts for more than a week at a time, or sometimes even continuously.