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RecruitingNAINTERVENTIONAL

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

This research is looking at two ways to treat people who have both a heart rhythm problem called atrial fibrillation (AF) and heart failure. Both AF and heart failure can make you feel breathless and tired. One treatment involves fitting a special pacemaker (conduction system pacing) and then a procedure called atrioventricular nodal ablation to stop fast, irregular signals from reaching the main pumping chambers of the heart. The other treatment is atrial fibrillation ablation, which involves targeting and blocking the faulty electrical signals causing AF. The study wants to find out which of these treatments is better at reducing hospital stays and improving overall health for patients. About 220 people from different European countries will take part, and the study will last about four years.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Geneva
Enrolment target
220
Start
01 Oct 2024
Estimated completion
01 Dec 2028

What is this study about?

This study is designed for individuals who have two specific heart conditions: persistent atrial fibrillation (AF) and heart failure. Persistent AF means your heart has a fast and irregular rhythm that doesn't go back to normal on its own. Heart failure, despite its name, doesn't mean your heart has stopped working, but rather that it's not pumping blood as efficiently as it should, leading to symptoms like breathlessness and tiredness. The combination of these two conditions can make daily life very challenging.

The main goal of this research is to compare two existing treatment approaches. Participants will be randomly assigned to one of two groups. One group will receive a special type of pacemaker that helps the heart beat in a more organised way (called conduction system pacing). Following this, they will have a procedure called atrioventricular nodal ablation, which carefully blocks off the electrical pathway between the top and bottom chambers of the heart to prevent irregular signals from AF from racing through. The other group will receive atrial fibrillation ablation, a procedure that aims to correct the irregular heart rhythm by finding and treating the areas in the heart causing the AF.

The researchers want to see which of these strategies leads to better outcomes, such as fewer hospital stays related to heart problems or heart failure, and overall improved health. This information will help doctors understand the best way to manage these complex conditions in the future and guide treatment choices for similar patients.

Key takeaways

  • This study compares two treatments for people with persistent atrial fibrillation and heart failure.
  • It aims to find out which treatment is better at improving health and reducing hospital stays.
  • You would be randomly assigned to receive either a pacemaker with a special procedure, or an atrial fibrillation ablation.
  • The study involves about 220 patients and will last approximately four years.
  • Participation includes medical procedures, close monitoring, and regular follow-up visits.

Who may be eligible?

To be considered for this study, you would need to be over 60 years old and have been diagnosed with long-lasting atrial fibrillation (AF) and heart failure that still causes symptoms, even with medication. You might also have been in hospital or visited a clinic for heart failure within the last two years, and blood tests would show certain levels related to heart strain.

You would also need to have tried some medication to control your heart rate or rhythm before. Crucially, the doctors must believe that you are a suitable candidate for the atrial fibrillation ablation procedure, and you should not have had more than one of these procedures in the past.

There are also reasons why you wouldn't be able to join. For example, if your heart failure is very severe (NYHA Class IV) with very low blood pressure, or if doctors believe you have less than two years to live, you wouldn't be suitable. You also can't participate if you need major surgery, have had a heart attack, stroke, or certain heart procedures in the last three months, or if you already have a special type of pacemaker (CRT device). Participating in another clinical trial or being unable to give informed consent would also exclude you.

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.

  1. Are you over 60 years old?
  2. Do you have long-lasting atrial fibrillation (AF) and heart failure that still causes symptoms?
  3. Have you tried medicines for your heart rate or rhythm before?
  4. Have you had no more than one previous AF ablation procedure?
  5. Are you able to provide consent and understand the study information?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive one of the two treatment options: either a pacemaker with a special procedure (conduction system pacing plus AV nodal ablation) or another heart procedure (atrial fibrillation ablation). The study involves several visits to the hospital for procedures and follow-up checks. You will continue to take your regular heart medications as advised by your doctor. Researchers will closely monitor your health, including performing tests and reviewing your medical records, to see how each treatment works for you. The total study duration for each patient will be about four years, involving regular contact with the study team during this time.

Potential risks and benefits

Participating in this study could potentially offer benefits, as you would receive one of two established treatments that could improve your heart condition and overall quality of life, with close monitoring from medical experts. However, like all medical procedures, both types of ablation and pacemaker implantation carry potential risks, which your doctor will explain in detail. These can include risks related to the procedures themselves, such as bleeding, infection, or damage to heart tissue. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • St Elisabeth sister's Hospital
    Verified postcode
    Graz, Austria· Not yet recruiting
  • Antwerp University Hospital
    Verified postcode
    Antwerp, Belgium· Not yet recruiting
  • Acibadem City Clinic Tokuda University Hospital
    Verified postcode
    Sofia, Bulgaria· Not yet recruiting
  • University Hospital, Kralovske Vinohrady
    Verified postcode
    Prague, Czechia· Not yet recruiting
  • Heart and Lung Center, University of Helsinki
    Verified postcode
    Helsinki, Finland· Recruiting
  • Hôpital Charles Nicolle
    Verified postcode
    Rouen, France· Not yet recruiting
  • Herzzentrum Leipzig
    Verified postcode
    Leipzig, Germany· Not yet recruiting
  • Semmelweis University
    Verified postcode
    Budapest, Hungary· Not yet recruiting
  • Bologna University Hospital
    Verified postcode
    Bologna, Italy· Not yet recruiting
  • University Hospital Maastricht
    Verified postcode
    Maastricht, Netherlands· Not yet recruiting
  • Jagiellonian University
    Verified postcode
    Krakow, Poland· Not yet recruiting
  • Hospital Universitario La Paz
    Verified postcode
    Madrid, Spain· Not yet recruiting

Common questions

What is atrial fibrillation (AF)?

AF is a heart condition where the top chambers of your heart beat irregularly and often too quickly, which can make you feel tired or breathless.

What is heart failure?

Heart failure means your heart isn't pumping blood as efficiently as it should to meet your body's needs, often causing symptoms like shortness of breath and swelling.

What does 'randomly assigned' mean?

It means you won't choose which treatment you get; a computer will decide, like flipping a coin. This ensures the study is fair.

Will I still take my regular medicines during the study?

Yes, you will continue with your usual heart medications unless your study doctor advises otherwise.

How long will the study last for me?

If you join, your participation and follow-up will last for about four years.

How to find out more

Haran Burri

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

Interested in taking part?

Register your interest

Share your details and the research team for "Atrial Fibrillation Ablation Versus Atrioventricular Nodal A…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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