Active not recruitingNAINTERVENTIONAL

Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

This study is investigating better ways to treat a specific type of irregular heartbeat called persistent atrial fibrillation. This condition can be challenging to manage, and current treatments don't always work perfectly. The study will look at a keyhole procedure known as catheter ablation. Doctors are comparing ablating (meaning, carefully burning or freezing small areas) of what they call 'low-voltage areas' in the heart. These areas might be slightly damaged and could be contributing to the irregular rhythm. The research aims to find out if targeting these specific areas, either by themselves or alongside other common ablation techniques, is more effective and safer for patients. The goal is to reduce the chances of the irregular heartbeat coming back after treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Robert Bosch Medical Center

Enrolment target

150

Start

01 Sep 2023

Estimated completion

01 Sep 2025

Persistent Atrial Fibrillation Catheter Ablation Low Voltage Areas

What is this study about?

You're probably reading this because you, or someone you know, has persistent atrial fibrillation. This is a common type of irregular heartbeat that can make you feel unwell. Doctors already have ways to treat it, often using a keyhole procedure called catheter ablation, which involves carefully 'burning' or 'freezing' small parts of the heart to stop the irregular signals. For some types of atrial fibrillation, this works really well, but for persistent atrial fibrillation, it can be more challenging to get a lasting result.

This study is trying to improve how we treat persistent atrial fibrillation. The researchers are particularly interested in certain areas of the heart that might be slightly damaged, which they call 'low-voltage areas.' It’s thought that these damaged areas might be part of what keeps the irregular heartbeat going. The study wants to see if targeting these specific damaged areas during an ablation procedure, either alone or with other established ablation techniques, makes the treatment more effective and reduces the chance of the irregular heartbeat returning.

The study will involve putting patients into different groups by chance (randomized). Some groups will have the standard ablation procedure, which usually involves treating the areas around the pulmonary veins (blood vessels leading to the heart). Other groups will receive treatments that also specifically target these 'low-voltage areas.' By comparing these different approaches, the doctors hope to find a better, more lasting way to help people with persistent atrial fibrillation.

Key takeaways

This study is looking for better treatments for persistent atrial fibrillation.
It focuses on a keyhole procedure called catheter ablation.
Researchers are comparing different ways to apply ablation, including targeting 'low-voltage areas' in the heart.
The goal is to find safer and more effective ways to stop the irregular heartbeat from coming back.
Participation involves being randomly assigned to one of three treatment groups.

Who may be eligible?

To be considered for this study, you need to have a specific type of irregular heartbeat called "persistent atrial fibrillation." This diagnosis will need to meet current medical guidelines. You also need to be an adult, aged at least 18 years old.

There's no upper age limit mentioned, but you can't be older than 85 years old. Both men and women are welcome to take part in this research.

Essentially, if you are under 18, or if your irregular heartbeat doesn't fit the description of persistent atrial fibrillation according to specific medical standards, you wouldn't be able to join this particular study.

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.

Do you have persistent atrial fibrillation?
Are you 18 years old or older?
Are you 85 years old or younger?
Are you willing to potentially receive different types of ablation treatment assigned by chance?

Answer every question to see your result.

What does participation involve?

The information provided does not give specific details about what taking part would involve in terms of visits, assessments, medication, or the total duration. However, it does mention that you would be assigned by chance to one of three different treatment groups. All groups would receive a procedure called 'pulmonary vein isolation' (PVI) which is a common type of catheter ablation. One group might receive PVI alone if no 'low-voltage areas' are found in their heart, another group might receive PVI alone even if these areas are detected, and a third group would receive PVI plus an additional ablation of any 'low-voltage areas' found. You would need to understand these different approaches before you agree to take part.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as receiving a new or improved treatment for your persistent atrial fibrillation and contributing to medical knowledge that could help many others. However, there are also potential risks involved with any medical procedure, including catheter ablation. These risks will be fully explained by the study team and could include bleeding, infection, or other complications, although serious problems are rare. You will be closely monitored throughout the study. It's very important to remember that joining this study is entirely your choice, and you have the right to withdraw at any time, for any reason, without affecting your future medical care.

Locations (1)

Robert Bosch Health Coampus
Verified postcode
Stuttgart, Germany

Common questions

What is 'persistent atrial fibrillation'?

It's a type of irregular heartbeat that doesn't usually go away on its own and tends to last for a longer time.

What is 'catheter ablation'?

It's a keyhole procedure where doctors use thin wires (catheters) to carefully 'burn' or 'freeze' small parts of your heart that are causing the irregular rhythm.

What are 'low-voltage areas'?

These are specific areas in the heart muscle that show signs of damage or scarring on special heart maps, and they might be contributing to the irregular heartbeat.

Why is this study important?

It aims to find better and more lasting ways to treat persistent atrial fibrillation, which can be challenging to manage with current methods.

Will I get to choose my treatment group?

No, you'll be put into one of the treatment groups by chance, like flipping a coin. This helps the researchers make fair comparisons.