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RecruitingNAINTERVENTIONAL

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

This research study is investigating a new artificial intelligence (AI) tool called vMap®. This tool helps doctors map the electrical signals in the heart, which can cause an irregular heartbeat known as Atrial Fibrillation (AF). The study aims to compare two ways of treating AF: using the standard procedure called Pulmonary Vein Isolation (PVI) on its own, versus using the vMap® tool to guide PVI. Half of the participants will receive PVI alone, and the other half will have their treatment guided by vMap® in addition to PVI. The goal is to find out if using vMap® leads to better results for adults living with AF. We want to see if this new technology can make the treatment more effective.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Vektor Medical
Enrolment target
423
Start
27 Jun 2025
Estimated completion
01 Dec 2027

What is this study about?

Many people in the UK live with a common heart condition called Atrial Fibrillation (AF), which causes an irregular and often very fast heartbeat. This can make you feel tired, breathless, or have palpitations. There are treatments available, and one common procedure is called Pulmonary Vein Isolation, or PVI. This procedure blocks abnormal electrical signals from the lungs that can cause AF.

This study is looking at a new tool called vMap®. Think of vMap® as a clever computer program that uses artificial intelligence to create a detailed map of your heart's electrical activity. Doctors believe this detailed map might help them pinpoint exactly where the irregular signals are coming from, making the PVI procedure even more precise and potentially more effective. The study wants to see if adding vMap® to the PVI procedure improves results compared to having PVI alone.

If you take part, you'll have an equal chance (50/50) of being in one of two groups. One group will receive the standard PVI treatment. The other group will have their PVI treatment guided by the vMap® system. This study will help doctors understand which approach works best for people with AF.

Key takeaways

  • The study compares a new AI tool (vMap®) for AF treatment.
  • It aims to see if vMap® helps make the PVI procedure more effective.
  • Half of participants get standard PVI, half get vMap®-guided PVI.
  • This research focuses on specific types of Atrial Fibrillation.
  • Participation involves your AF procedure and follow-up checks.

Who may be eligible?

This study is looking for adults aged 22 or older who have been diagnosed with a specific type of Atrial Fibrillation (AF). This includes AF that is 'persistent' (meaning it doesn't go away on its own but hasn't lasted for a very long time) or 'recurrent' (meaning it comes and goes). You must be considered suitable for a heart ablation procedure by your doctor, and have had recent ECG recordings of your heart activity.

However, you won't be able to join if you have a different type of AF, especially if your AF has been persistent for a year or more. You also can't take part if you're pregnant, or if the quality of your heart's electrical recordings (ECGs) isn't clear enough for the study. If you're already involved in another clinical trial with a new medication or device, or if your doctor thinks taking part might put your health at risk, you also won't be able to join.

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 22 years old or older?
  2. Have you been diagnosed with 'persistent' or 'recurrent' AF (not very long-term AF)?
  3. Is your doctor recommending you for a heart ablation procedure?
  4. Do you have clear, recent ECG recordings of your heart activity?
  5. Are you NOT currently pregnant or involved in another major clinical trial?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have an initial assessment. Then, you'll be randomly put into one of two groups: either you'll receive the standard PVI procedure, or you'll have the PVI procedure guided by the vMap® system. The actual heart procedure will be just like a normal PVI, but for one group, the vMap® tool will be used to help plan it. You'll need to attend follow-up appointments after your procedure so the study doctors can see how you're doing. The total length of your participation, including follow-up, will be explained to you in detail.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more effective AF treatment if the vMap® guided approach proves superior. However, there's also a chance you'll be in the standard treatment group. As with any medical procedure, there are potential risks associated with the PVI procedure itself, and these will be fully explained by your doctor. Your safety is paramount, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

  • Arrhythmia Research Group - St. Bernards
    Verified postcode
    Jonesboro, United States· Recruiting
  • BayCare Health System
    Verified postcode
    Clearwater, United States· Recruiting
  • Baptist Health Jacksonville
    Verified postcode
    Jacksonville, United States· Recruiting
  • USF Health
    Verified postcode
    Tampa, United States· Recruiting
  • Piedmont Heart of Athens
    Verified postcode
    Athens, United States· Not yet recruiting
  • Piedmont Heart Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Indiana University
    Verified postcode
    Indianapolis, United States· Recruiting
  • Baptist Health Lexignton
    Verified postcode
    Lexington, United States· Recruiting
  • Westchester Medical Center
    Verified postcode
    Valhalla, United States· Recruiting
  • OhioHealth
    Verified postcode
    Columbus, United States· Recruiting
  • University of Toledo Medical Center
    Verified postcode
    Toledo, United States· Not yet recruiting
  • Penn Presbyterian
    Verified postcode
    Philadelphia, United States· Recruiting

Common questions

What is Atrial Fibrillation (AF)?

AF is a common heart condition that causes an irregular and often very fast heartbeat, leading to symptoms like tiredness or breathlessness.

What is PVI?

PVI, or Pulmonary Vein Isolation, is a standard procedure used to block abnormal electrical signals in the heart that cause AF.

What is vMap®?

vMap® is an artificial intelligence tool that creates detailed maps of your heart's electrical activity to help guide AF treatment.

Will I know which treatment I'm receiving?

You will have a 50/50 chance of receiving either the standard PVI or PVI guided by vMap®. This is decided randomly.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, and it won't affect your medical care.

How to find out more

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 "Artificial Intelligence Mapping and Ablation of Non-Pulmonar…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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