Active not recruitingNAINTERVENTIONAL

Dispersion Stability

This study is investigating a treatment technique called AF ablation for people with an irregular heartbeat called atrial fibrillation (AF). The main goal is to see how well treating certain areas of the heart can stop AF immediately. The researchers also want to map out these specific heart areas. They will be keeping track of any unwanted side effects that might happen. A significant part of the study is to check if this treatment keeps AF from coming back for a whole year after the procedure. This research aims to improve how doctors treat AF to help patients maintain a normal heart rhythm.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hospital St. Joseph, Marseille, France

Enrolment target

Start

05 Aug 2021

Estimated completion

28 Jan 2025

Atrial Fibrillation

What is this study about?

This study is about a heart condition called atrial fibrillation, or AF. With AF, the top chambers of your heart beat irregularly and too fast. This can make you feel tired, dizzy, or short of breath, and it increases your risk of stroke. Doctors often treat AF with a procedure called ablation. This involves using heat or cold to create tiny scars in your heart tissue, which helps block the electrical signals causing the irregular beat.

In this particular study, doctors are focusing on a specific type of ablation. They are trying to find and treat very precise areas in the heart that are thought to be key to maintaining AF. The study aims to see if targeting these specific areas works well to stop the irregular heartbeat right away. They also want to understand exactly where these 'problem' spots are located within the heart.

Ultimately, the goal is to improve how AF is treated. By understanding if targeting these specific areas is effective, doctors hope to develop better ways to help people with AF return to a normal heart rhythm and stay that way for a longer time, potentially for at least a year after the treatment. This could mean a better quality of life for many patients.

Key takeaways

This study aims to improve long-lasting atrial fibrillation (AF) treatment.
It focuses on a specific type of heart ablation procedure.
Researchers will check if treating certain heart areas effectively stops AF.
The study will track heart rhythm for 12 months after the treatment.
Participants must be aged 18 or over with specific types of AF.

Who may be eligible?

This study is looking for adults aged 18 or older who have a long-lasting type of atrial fibrillation (AF). You would need to have had AF for at least three months but no more than five years, or have had AF come back for at least three months after a previous treatment to restore a normal rhythm. It's also important that you've been taking blood-thinning medication, like warfarin or a NOAC, for over a month before the procedure.

However, some things would mean you couldn't join. This includes if your AF is quite new (less than three months), or if you have severe obesity (a BMI over 45). You also wouldn't be able to participate if a scan shows a blood clot in your heart, or if you can't take blood thinners. We also can't include pregnant or potentially pregnant individuals.

Other reasons you might not be eligible include having had recent heart surgery or a heart attack within the last two months, a history of serious bleeding or clotting problems, or a recent stroke-like event within the last year. If you have an active infection, including COVID-19, or if you're already in another study testing a new treatment, you wouldn't be able to take part. Also, if you have another serious health condition that means you're not expected to live for at least another year, this study wouldn't be suitable.

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?
Do you have a long-lasting type of atrial fibrillation (AF)?
Have you been taking blood-thinning medication for over a month?
Are you not pregnant or planning to become pregnant?
Have you *not* had heart surgery or a heart attack in the last two months?
Do you *not* have an active infection like COVID-19?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have the AF ablation procedure to treat your irregular heartbeat. Before the procedure, you'll have various tests to check your heart and general health. The study will look closely at what happens during the ablation, specifically how quickly your AF stops. After the procedure, you'll be monitored for any side effects.

The main part of the follow-up will be over the next 12 months. During this time, the medical team will check regularly to see if your AF has stayed away. This will likely involve clinic visits and possibly tests like ECGs or Holter monitors (small devices that record your heart rhythm over a period). You will continue to take your prescribed medications, including blood thinners, as advised by your doctor. The total duration of your participation in the study from the start of the ablation to the end of the follow-up period will be approximately 12 months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a more effective treatment for your atrial fibrillation, potentially leading to a lasting normal heart rhythm. However, like any medical procedure, AF ablation carries some risks such as bleeding, infection, or damage to heart tissue. The researchers will be carefully monitoring for any side effects. Your safety and well-being are a top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hôpital Saint Joseph Marseille
Verified postcode
Marseille, France

Common questions

What is AF ablation?

AF ablation is a procedure where doctors use heat or cold to create tiny scars in your heart to block abnormal electrical signals causing an irregular heartbeat (atrial fibrillation).

What is the main goal of this study?

The main goal is to see if treating very specific areas of the heart during ablation can stop atrial fibrillation immediately and keep it away for a year.

Will I need to take medication during the study?

Yes, you will continue to take your prescribed medications, including blood thinners, as advised by your doctor throughout the study.

How long will I be involved in the study?

You will be involved for about 12 months, which includes the ablation procedure and a year of follow-up to check your heart rhythm.

Can I leave the study if I change my mind?

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