Active not recruitingOBSERVATIONAL

Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation

This study is checking how a new artificial intelligence (AI) software, called Volta Medical AI, helps doctors treat an irregular heartbeat called atrial fibrillation (AF) by a procedure known as ablation. Doctors use this AI tool during the procedure to find specific areas in the heart that cause the irregular rhythm. The study will observe how safe and effective this AI-guided approach is for patients over time, up to two years after the procedure, in regular hospital care. It also looks at the costs involved. Researchers want to see the real-world benefits without changing how doctors usually work, focusing on how patients feel and whether their irregular heartbeats come back. This helps understand if the new AI tool improves AF treatment.

At a glance

Status

Active not recruiting

Sponsor

Volta Medical

Enrolment target

186

Start

27 Oct 2023

Estimated completion

27 Apr 2027

Atrial Fibrillation Atrial Arrhythmia Arrhythmias, Cardiac

What is this study about?

This research is looking into a new way to treat an irregular heartbeat condition called atrial fibrillation (AF), which can make your heart beat too fast or unevenly. Doctors often treat AF with a procedure called catheter ablation. This procedure involves using a special catheter (a thin, flexible tube) to create small scars in the heart tissue that are causing the irregular signals, helping to restore a normal heart rhythm.

In this study, doctors are using an innovative artificial intelligence (AI) software from Volta Medical. This AI tool helps them during the ablation procedure by pinpointing the specific areas in the heart that are causing the AF. The aim is to see how well this AI-guided approach works in real-life hospital settings across Europe. This means doctors will use the AI software as part of their usual practice, without being told to change their standard treatment methods. The study will follow patients for up to two years to see if the treatment is safe, if their AF comes back, and how it affects their quality of life.

Additionally, the study will collect information about the costs involved with using this AI-guided treatment. This helps healthcare providers understand if this new technology is not only effective for patients but also makes economic sense in the long run. By studying patients in their normal care environment, researchers hope to get a clear picture of the true benefits of using this AI software for AF ablation.

Key takeaways

This study evaluates AI software for treating irregular heartbeats (AF).
It aims to observe safety and effectiveness in real hospitals.
Patients will be followed for up to two years after their ablation.
The study also looks at the costs involved with using AI.
Your routine medical care remains unchanged as part of the study.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled to have an ablation procedure to treat their atrial fibrillation (AF) or atrial arrhythmia. This includes people who are having ablation for the first time, or those who have had one or more ablation procedures before.

Crucially, your doctor must think that using the Volta Medical AI software (known as VX1 or Volta AF-Xplorer or Volta AF-Xplorer II) during your ablation procedure is a good option for your treatment. You also need to be willing and able to give your written permission to take part in the study.

There are certain reasons why you wouldn't be able to join. For example, if your doctor advises against having an ablation procedure at all, or if you are pregnant or could become pregnant. People who are in prison, under guardianship, or who live in a way that makes regular medical check-ups difficult are also not able to participate. Lastly, if you are already taking part in another study that's testing a different medical device, treatment, or drug, you cannot join this one.

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?
Are you scheduled for an ablation for atrial fibrillation or a similar arrhythmia?
Has your doctor suggested using the Volta Medical AI software for your procedure?
Are you willing to give written consent to participate?
Are you not pregnant or potentially pregnant?
Are you not currently in another device or drug trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have your planned catheter ablation procedure for atrial fibrillation, during which your doctor will use the Volta Medical AI software to help guide the treatment. After your procedure, you will have follow-up appointments, just as you would normally, to check on your recovery and heart health.

These follow-up visits will typically happen around 3, 6, and/or 9 months after your ablation, and then yearly for up to 24 months (two years). During these visits, doctors will check for any complications, see if your irregular heartbeat has returned, and ask about any symptoms you might be experiencing. You will also be asked to complete a general health quality-of-life questionnaire before your procedure and at your annual follow-up visits. The study will end for you after your last annual visit at 24 months.

Potential risks and benefits

Taking part in this study means your ablation procedure will include the use of new AI software, which might help your doctor more accurately target the irregular heart signals. However, this is an observational study, meaning it mainly watches what normally happens in clinical practice without changing your usual care. The risks associated with the ablation procedure itself are the same as if you weren't in the study. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (7)

Hôpital Saint-Joseph
Verified postcode
Marseille, France
Hôpital Privé Jacques Cartier
Verified postcode
Massy, France
Polyclinique Saint George
Verified postcode
Nice, France
Centre Cardiologique du Nord
Verified postcode
Saint-Denis, France
Clinique Rhéna
Verified postcode
Strasbourg, France
Clinique Pasteur
Verified postcode
Toulouse, France
German Heart Center Munich
Verified postcode
München, Germany

Common questions

What is atrial fibrillation (AF)?

Atrial fibrillation (AF) is a common heart condition that causes an irregular and often abnormally fast heart rate.

What is catheter ablation?

Catheter ablation is a procedure that creates small scars in the heart to block faulty electrical signals and restore a normal heart rhythm.

What does the AI software do?

The AI software helps doctors identify specific areas in your heart that are causing the irregular heartbeat during the ablation procedure.

How long will the study follow me?

The study will follow you for up to 24 months (two years) after your ablation procedure.

Will my regular medical care change if I join?

No, this study observes standard medical practice; your regular care and treatment approach will not be changed by participating.