Not yet recruitingNAINTERVENTIONAL

Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair

This study is for people who have an irregular heartbeat called atrial fibrillation (AF) and have recently had a procedure to fix a leaky heart valve (mitral valve repair). We want to find out if an additional procedure, called catheter ablation, can help these patients more than their usual care. Catheter ablation is a keyhole procedure that aims to correct the irregular heart rhythm. The study will compare patients who have ablation with those who continue with their standard treatments. We will look at whether ablation helps reduce the chances of serious heart events, like strokes or heart failure, in the long run. By doing this research, we hope to improve care for people with both AF and a history of leaky heart valves.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Atrial Fibrillation Network

Enrolment target

956

Start

01 Jul 2026

Estimated completion

31 Jan 2032

Atrial Fibrillation (AF)Mitral Valve (MV) Regurgitation

What is this study about?

You might be familiar with atrial fibrillation (AF), which is a common condition where the heart beats irregularly. This can increase the risk of other serious health issues, including strokes and heart problems. Many people with AF also have a leaky heart valve, specifically the mitral valve, which is a common heart problem, especially as people get older. These two conditions often affect each other and can make symptoms worse.

Recently, a procedure called transcatheter edge-to-edge mitral valve repair (TEER) has become available to fix leaky mitral valves without major surgery. For patients who have had this repair, AF can still be a problem. We know that in some other heart conditions, a procedure called catheter ablation can be very helpful in managing AF and improving outcomes. Catheter ablation is a procedure where doctors use thin, flexible wires (catheters) to reach the heart and block the faulty electrical signals that cause AF. While we have some early ideas that ablation might be helpful for people who have had a TEER, we need to test this properly.

This study, called CABA-MiTRA-AFNET12, aims to look closely at whether catheter ablation, alongside your usual care, is better at preventing serious heart problems for patients who have had a successful TEER and also have AF. Half the patients in the study will receive catheter ablation along with their standard treatment, and the other half will continue with their standard treatment only. By comparing these two groups, we hope to find clear evidence about the best approach to care for you.

Key takeaways

This study compares catheter ablation to usual care for people with atrial fibrillation and a repaired leaky heart valve.
It aims to see if ablation can better prevent serious heart problems like strokes.
Participants will be randomly assigned to either receive ablation or continue with standard treatments.
The study focuses on adults who recently had a successful mitral valve repair.
It's an important step in understanding the best care for these complex heart conditions.

Who may be eligible?

To join this study, you would need to be an adult over 18 years old. You must have irregular heartbeats (atrial fibrillation) that has been officially diagnosed by a doctor. Also, you would have needed to have a specific type of heart valve repair procedure, called transcatheter edge-to-edge mitral valve repair (TEER), between one month and six months ago. This repair must have been successful, meaning your mitral valve isn't leaking much anymore.

There are also some reasons why you wouldn't be able to join. For example, if you've already had a previous procedure to treat your atrial fibrillation, or if you've had a recent heart attack, stroke, or major surgery within the last two months. If you are pregnant or breastfeeding, or if your doctors think you're not healthy enough for the ablation procedure for any reason, you wouldn't be able to participate. Also, if you are already in another trial or if your doctors believe you have a very short life expectancy (less than a year), you wouldn't be eligible.

The study also checks for things like untreated thyroid problems, mental or physical difficulties that would prevent you from taking part fully, or if you have any other planned major heart procedures in the near future. The study team will review all these factors carefully with you to see if the study is a good fit.

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?
Have you been diagnosed with atrial fibrillation (AF)?
Did you have a transcatheter edge-to-edge mitral valve repair (TEER) between 1 and 6 months ago?
Was your TEER procedure successful (valve not leaking much)?
Have you NOT had a previous AF ablation procedure?
Have you NOT had a heart attack or stroke in the last 2 months?

Answer every question to see your result.

What does participation involve?

If you agree to take part in this study, you would first undergo some health checks to make sure you're eligible. If you are, you would then be randomly assigned to one of two groups: either receiving catheter ablation in addition to your usual care, or continuing with just your usual care. You wouldn't be able to choose which group you are in.

Throughout the study, you would have regular follow-up visits and assessments. These usually involve checking your heart health, possibly with scans or ECGs, and discussing your symptoms and general well-being. The exact number and timing of visits would be explained in full by the study team, but they are designed to monitor your health and how well the treatments are working. The total time you would be involved in the study could span several years to properly assess the long-term effects.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For patients in the ablation group, potential benefits include an improved heart rhythm, which could reduce symptoms related to AF and possibly lower the risk of serious heart problems like stroke. However, ablation is a medical procedure and carries risks, such as bleeding, infection, or damage to heart tissue, though these are relatively rare. For those in the usual care group, there are no additional risks beyond standard medical care, but they might not experience potential benefits that the ablation could offer. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (4)

University Hospital Cologne
Verified postcode
Cologne, Germany
University Heart and Vascular Center Frankfurt
Verified postcode
Frankfurt, Germany
Asklepios Hospital St. Georg
Verified postcode
Hamburg, Germany
University Hospital Münster
Verified postcode
Münster, Germany

Common questions

What is atrial fibrillation (AF)?

AF is an irregular and often very rapid heartbeat that can increase your risk of stroke, heart failure, and other heart-related complications.

What is a leaky mitral valve?

The mitral valve is one of your heart's valves. If it's 'leaky,' it means it doesn't close properly, allowing blood to flow backward in your heart, making it work harder.

What is catheter ablation?

Catheter ablation is a procedure where doctors use flexible wires (catheters) to create small scars in your heart tissue to block faulty electrical signals that cause AF, helping to restore a normal heart rhythm.

What is 'usual care' in this study?

Usual care means the standard medical treatments and follow-up you would normally receive for your atrial fibrillation and heart condition, without adding the catheter ablation procedure from the study.

Will I have to pay to participate?

No, all study-related treatments and assessments are typically provided free of charge when participating in a clinical trial.

How to find out more

Vincent Beuger, PhD

caba-mitra@af-net.eu +49 251 276001 64 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.