All studies
RecruitingNAINTERVENTIONAL

Atrial Flutter Ablation in the iCMR

This study, called VISABL-AFL, is investigating a new treatment for a common type of irregular heartbeat called atrial flutter. The treatment involves a procedure called radiofrequency (RF) ablation, which uses heat to correct the heart's electrical signals. What's new here is that this procedure is guided by a special MRI scanner during the treatment itself. The study aims to see how safe and how well this new approach works for people aged 18 and older who have typical atrial flutter. If you've had a recent episode of this condition and meet certain health criteria, you might be able to take part.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Imricor Medical Systems
Enrolment target
91
Start
20 Jun 2024
Estimated completion
31 Dec 2026

What is this study about?

This research is looking into a different way to treat a condition called atrial flutter. Atrial flutter is a type of irregular heartbeat where the upper chambers of your heart (the atria) beat too quickly and in a regular, but still abnormal, rhythm. This can make you feel tired, breathless, or have a fluttering sensation in your chest.

The standard treatment for atrial flutter often involves a procedure called radiofrequency ablation. This uses a thin tube, or catheter, to deliver heat to small areas of heart tissue that are causing the irregular beats. This study is testing whether performing this ablation procedure while using a special type of MRI scanner at the same time (known as an iCMR environment) can make the treatment more precise and effective.

The main goal of this study is to understand if this new, MRI-guided ablation is both safe and works well for people with typical atrial flutter. By taking part, you could be helping doctors learn more about the best ways to treat this common heart condition, potentially leading to better outcomes for patients in the future.

Key takeaways

  • This study explores a new way to treat atrial flutter.
  • It uses radiofrequency ablation guided by MRI.
  • Aims to check safety and effectiveness for adults with atrial flutter.
  • Could help improve future treatments for heart rhythm problems.
  • Participation involves the procedure and follow-up checks.

Who may be eligible?

To join this study, you need to be an adult (18 or older) and have been diagnosed with a specific type of atrial flutter (Type I) within the last six months. You also need to be suitable for medical procedures like an MRI scan.

However, there are some reasons why you might not be able to take part. For example, if you have certain types of heart problems, like a recent heart attack or unstable chest pain, or if you've had heart surgery recently. You also can't participate if you have something inside your heart that would make the procedure difficult, or if you're pregnant. The doctors will carefully review your health to make sure the study is safe for 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 18 years old or older?
  2. Have you been diagnosed with typical atrial flutter in the last 6 months?
  3. Can you safely have an MRI scan?
  4. Do you have any severe heart conditions like a recent heart attack?
  5. Are you pregnant or planning to become pregnant during the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of it will be the atrial flutter ablation procedure itself, which will be performed using an MRI scanner to guide the treatment. Before the procedure, you'll have several checks, including detailed heart tests, and you'll need to stop certain heart rhythm medications (if you're taking them) on the day of the procedure. You'll also have follow-up appointments after the procedure to see how you're recovering and if the treatment has been successful. The total duration of your involvement will depend on the study's follow-up schedule, but it's designed to monitor your health and the treatment's effect over time.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a new, potentially more precise, way to treat your atrial flutter. However, like any medical procedure, radiofrequency ablation carries some risks, such as bleeding, infection, or damage to blood vessels. The use of MRI during the procedure also has its own set of considerations. The study team will explain all known risks and benefits in detail before you decide to participate. Remember, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (6)

  • Johns Hopkins University (JHU)
    Verified postcode
    Baltimore, United States· Recruiting
  • University of Virginia (UVA)
    Verified postcode
    Charlottesville, United States· Not yet recruiting
  • Virginia Commonwealth University
    Verified postcode
    Richmond, United States· Not yet recruiting
  • l'institut Cardiologique Paris Sud (ICPS)
    Verified postcode
    Massy, France· Recruiting
  • Amsterdam University Medical Center (AUMC)
    Verified postcode
    Amsterdam, Netherlands· Recruiting
  • University Hospital of Vaud (CHUV)
    Verified postcode
    Lausanne, Switzerland· Recruiting

Common questions

What is atrial flutter?

Atrial flutter is a type of irregular heartbeat where the top chambers of your heart beat very fast, but usually in a regular pattern.

What is radiofrequency ablation?

It's a procedure that uses heat to carefully destroy small areas of heart tissue that are causing the irregular heartbeat, helping to restore a normal rhythm.

What does 'guided by MRI' mean?

It means doctors will use a special MRI scanner during the ablation procedure to see what they are doing inside your heart, aiming for more accuracy.

How long will I be in the study?

The study involves the procedure itself and follow-up checks afterwards. The exact duration for you will be explained by the study team.

Can I leave the study if I change my mind?

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

How to find out more

Kate Lindborg

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 Flutter Ablation in the iCMR…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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