Not yet recruitingOBSERVATIONAL

VOLta Medical AI-software in REal-World During AF Ablation

This study, called "VOLTAIRE-AF," is checking a new computer program called Volta AF-Xplorer II. This program uses artificial intelligence (AI) to help doctors during a procedure called catheter ablation, which treats an irregular heartbeat called atrial fibrillation. The main goal is to see how safe and effective this new AI software is when used in everyday medical practice. Doctors will follow patients for up to two years to see how they are doing after the procedure, looking at things like their heart rhythm and general well-being. The study wants to understand how this new technology helps in real-world situations, without changing how doctors normally work.

At a glance

Status

Not yet recruiting

Sponsor

Volta Medical

Enrolment target

150

Start

01 Jun 2026

Estimated completion

01 Jun 2030

Atrial Fibrillation Atrial Arrhythmia Arrhythmias, Cardiac

What is this study about?

This study, known as "VOLTAIRE-AF," is looking into a new computer system called Volta AF-Xplorer II. This system uses artificial intelligence, or AI, to help doctors treat a common condition called atrial fibrillation (AF). AF is an irregular and often very fast heartbeat that can cause you to feel dizzy, breathless, or very tired. One way to treat AF is with a procedure called catheter ablation.

During a catheter ablation, doctors use thin, flexible wires (catheters) guided into your heart to find and fix the areas causing the irregular rhythm. The Volta AF-Xplorer II software assists doctors during the first part of this procedure by helping them pinpoint exactly where in the heart the problem areas are located. The study aims to gather information on how well this AI software works alongside the latest ablation techniques and how safe it is for patients in real-life clinical settings. Doctors will continue to use their usual methods for the ablation itself, ensuring the study reflects everyday medical practice.

By following patients for two years, the study hopes to learn if using this AI software makes a difference in terms of how successful the ablation is and how patients feel in the long term. This information will help doctors understand the benefits of this new technology for people with atrial fibrillation.

Key takeaways

This study uses new AI software to help with atrial fibrillation ablation.
It aims to see how safe and effective the software is in real-life care.
You'll be followed for up to two years after your procedure.
Your medical care for the ablation will be similar to standard practice.
The study is for people needing ablation for atrial fibrillation or similar fast heartbeats.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You should be a candidate for a catheter ablation procedure to treat atrial fibrillation or a similar fast heartbeat, whether it's your first ablation or you've had one before. Your doctor must also think that using the Volta AF-Xplorer II software would be a good option for your treatment within the study.

You also need to be able and willing to fully understand and sign a consent form that explains everything about the study. If you're in France, you'll need to be part of the French social security system. It's important that you don't have any medical reasons that would prevent you from having an ablation procedure.

You cannot take part if you are pregnant or could become pregnant. Also, if you are currently involved in another study testing a new drug, device, or treatment, you wouldn't be able to join this one. Finally, if you are unable to attend regular medical appointments due to where you live, social reasons, or psychological challenges, or if you simply don't want to participate, you won't be included in the study.

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 over?
Are you scheduled for an ablation for atrial fibrillation or a similar fast heartbeat?
Are you able and willing to sign a consent form?
Are you not pregnant or planning to be pregnant?
Are you not currently in another device or drug study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your experience will largely be similar to what you would expect if you were having a standard catheter ablation for atrial fibrillation. You will have your ablation procedure as planned, and during the "mapping" phase of this procedure, the Volta AF-Xplorer II software will be used to help identify specific areas in your heart. The actual ablation technique will be chosen by your doctor based on what they usually recommend.

After your procedure, you'll have follow-up visits, just as you would under normal care. These will typically be at 3 months, 6 months (or 9 months, depending on your doctor's usual practice), and then annually for up to 24 months after your ablation. During these visits, doctors will check for any side effects, see if your irregular heartbeat has returned, and ask about your heart-related symptoms and general well-being using some questionnaires. The total duration of your participation in the study will be two years, ending with your last annual visit.

Potential risks and benefits

Participating in this study might offer the potential benefit of having your ablation procedure guided by cutting-edge AI software. However, it's important to remember that this software is still being evaluated, and we don't yet know if it will definitely lead to a better outcome than standard care. As with any medical procedure, there are potential risks associated with catheter ablation itself, which your doctor will explain fully. The study aims to monitor these very carefully. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

Hôpital Saint-Joseph Marseille
Verified postcode
Marseille, France
Centre Cardiologique du Nord
Verified postcode
Saint-Denis, France
Clinique Rhéna
Verified postcode
Strasbourg, France

Common questions

What is atrial fibrillation?

Atrial fibrillation (AF) is an irregular and often very fast heartbeat. It can make you feel breathless, dizzy, or very tired.

What is catheter ablation?

It's a procedure where a doctor uses thin, flexible wires guided into your heart to find and correct the areas causing an irregular heartbeat.

What does the AI software do?

The Volta AF-Xplorer II software uses artificial intelligence to help your doctor find the specific problem areas in your heart more accurately during the ablation procedure.

How long will I be in the study?

You will be followed for up to two years after your ablation procedure.

Will my treatment be different if I join the study?

Your actual ablation procedure will be done using your doctor's usual methods. The main difference is the use of the AI software to help during the initial part of the procedure.

How to find out more

Paola MILPIED

paola.milpied@volta-medical.com +33768025499 Official trial record

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