Active not recruitingOBSERVATIONAL

Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation

Doctors are studying people with a common heart condition called atrial fibrillation, which causes an irregular heartbeat. These patients are planning to have a procedure called catheter ablation, which tries to fix the irregular beat. Before the ablation, they will have a special scan that measures the amount of fat around their heart. After the procedure, the doctors will check if their irregular heartbeat returns after 3 and 6 months. The main goal is to understand if having more or less fat around the heart affects how successful the catheter ablation is at keeping the heart rhythm steady. This is an observational study, meaning researchers are watching and collecting information, not giving new treatments.

At a glance

Status

Active not recruiting

Sponsor

Deutsches Herzzentrum Muenchen

Enrolment target

200

Start

18 Aug 2022

Estimated completion

30 Jun 2025

Atrial Fibrillation

What is this study about?

This study is gathering information about people who have a common heart condition called atrial fibrillation (AF). AF makes your heartbeat irregular and often very fast. One way doctors try to fix this is with a procedure called catheter ablation, which uses heat or cold to block the faulty electrical signals in the heart that cause AF.

Before patients have their first catheter ablation, they will have a special type of scan called a CT scan. This scan will look closely at the fat around the outside of the heart, sometimes called 'epicardial fat'. The researchers want to measure exactly how much of this fat there is. After the ablation procedure, the doctors will follow up with patients for 3 and 6 months to see if their irregular heartbeat comes back. They want to find out if the amount of fat around the heart affects whether the ablation is successful in keeping the heart's rhythm regular.

By understanding this better, doctors might be able to predict who will benefit most from catheter ablation or perhaps develop new ways to improve the success rate for patients with atrial fibrillation in the future. This is an observational study, which means doctors are not testing a new medicine or treatment, but rather just collecting information about an existing one to learn more.

Key takeaways

This study helps understand atrial fibrillation and ablation.
It measures heart fat before a planned ablation.
No new treatments or procedures are given.
Involves follow-up for 6 months after ablation.
Aims to improve care for future patients.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) and have atrial fibrillation that your doctor plans to treat with your first catheter ablation procedure. You also need to be able to understand the study and provide your written permission to take part. Finally, you must be scheduled to have a special CT scan as part of your usual care before the ablation.

There are some reasons why you wouldn't be able to join. For example, if you've already had a catheter ablation for your heart, you can't participate. Also, if you are under 18 or can't give your consent, you wouldn't be eligible. If you have any health conditions that make a CT scan with special dye unsafe for you, like a severe allergy to the dye, serious kidney problems, or overactive thyroid, you won't be able to join.

Other reasons you wouldn't be able to join include if you were born with a heart defect or have had heart surgery in the past. The study is open to both men and women.

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 atrial fibrillation?
Are you scheduled for your first catheter ablation?
Are you able to agree to take part in writing?
Do you have plans for a CT scan before your ablation?
Have you NOT had a previous heart ablation or heart surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special CT scan before your planned catheter ablation. This scan will measure the fat around your heart. After your ablation procedure, the study will simply involve doctors checking on your heart rhythm to see if your atrial fibrillation has returned. These checks will happen at 3 months and again at 6 months after your ablation. You won't need extra visits just for the study; these follow-up checks are typically part of your usual care after an ablation. The total duration of your involvement in the study would be about 6 months, simply following up on the results of your ablation.

Potential risks and benefits

Taking part in this study doesn't involve any new treatments or extra procedures beyond what your doctor has already planned for your atrial fibrillation. The main benefit is that you would contribute to medical knowledge, which could help future patients with atrial fibrillation. There are no direct personal benefits or risks from the study itself, as it's observational. The CT scan is a standard procedure and carries its own small, known risks, which your doctor would discuss with you. You are free to stop participating in the study at any time without affecting your medical care.

Locations (1)

Deutsches Herzzentrum
Verified postcode
München, Germany

Common questions

What is atrial fibrillation?

It's a condition where the heart beats irregularly and often very fast, which can cause symptoms like breathlessness or tiredness.

What is catheter ablation?

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

What is 'epicardial fat'?

It's the fat that is found directly on the surface of your heart. Researchers want to see if the amount of it affects ablation success.

Do I get a new treatment in this study?

No, this study only observes people undergoing planned treatments. You won't receive any new medications or procedures as part of the study.

How long will I be followed up?

Doctors will check on your heart rhythm at 3 months and 6 months after your ablation procedure.