RecruitingOBSERVATIONAL

Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

This research is a follow-up to an earlier study on persistent atrial fibrillation (a type of irregular heartbeat). It's called TAILORED-LT and it's looking at people who already took part in the TAILORED-AF study. The main goal is to find out if a newer treatment strategy, which uses a special AI-guided device called Volta AF-Xplorer, is better at keeping people free from AF over five years than the standard treatment. The standard treatment involves isolating specific areas in the heart called pulmonary veins (PVI), while the new 'tailored' approach combines PVI with targeting other specific areas identified by the AI system. This study will simply check in with participants annually rather than giving new treatments.

At a glance

Status

Recruiting

Sponsor

Volta Medical

Enrolment target

278

Start

06 Mar 2025

Estimated completion

31 Dec 2027

Atrial Fibrillation

What is this study about?

Imagine your heart sometimes beats really fast and unevenly – this is called atrial fibrillation (AF). For some people, this happens often and is called 'persistent AF'. Doctors have different ways to treat this, including a procedure called ablation, which uses heat or cold to create tiny scars in your heart to block the faulty electrical signals.

This study, called TAILORED-LT, is a long-term check-up for people who have already had an ablation procedure as part of an earlier study (TAILORED-AF). The earlier study looked at two main ways of doing ablation: one was the standard method where doctors targeted specific areas (PVI), and the other was a newer, 'tailored' approach that also used a special AI-guided device (Volta AF-Xplorer) to find and treat additional areas causing the irregular beats. The first study showed that the tailored approach seemed more effective after one year. Now, this new study wants to see which method keeps people free from AF for a much longer time – up to five years.

By following people for five years, researchers hope to clearly show which ablation method (the standard one or the AI-guided tailored one) offers the best long-term results for people with persistent atrial fibrillation. This is important because it could help doctors choose the most effective treatment for patients in the future.

Key takeaways

This study follows up on previous AF ablation treatments.
It compares a standard ablation to an AI-guided 'tailored' ablation.
The main goal is to see which treatment works best over five years.
Participation involves annual check-ups, Holter monitors, and questionnaires.
No new treatments are given as part of this follow-up study.
Your involvement helps improve future AF treatments.

Who may be eligible?

To be part of this long-term study, you must have already taken part in the original TAILORED-AF study. You also need to have completed the first 12 months of follow-up in that study without dropping out. Finally, you must be able and willing to give your written permission to join this extension study.

There are a few reasons why someone might not be able to join. For example, if you are currently in prison or under legal guardianship, you wouldn't be able to participate. Also, if your living situation or personal circumstances would make it difficult for you to attend follow-up appointments and check-ups, you might not be eligible. The study needs to make sure participants can reliably attend appointments and complete tests.

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.

Did you complete the original TAILORED-AF study?
Did you stay in the TAILORED-AF study for the full 12 months?
Are you able and willing to sign a consent form to join?
Do you feel you can attend annual appointments over several years?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new treatments specifically for the study itself. Instead, the study will simply follow your health journey over several years. You will have annual check-ups at 2, 3, 4, and 5 years after your original ablation procedure in the TAILORED-AF study. These visits are similar to the routine check-ups you would normally have after AF ablation.

During these annual visits, you will have a special heart monitor called a 24-hour Holter monitor (which records your heart activity for a full day). You will also be asked to fill out questionnaires about your quality of life, which help understand how your AF and its treatment affect your daily living. Some of the earlier annual visits might be gathered using information from your medical records if time has already passed since the first study ended. The total duration of your participation will be up to five years from your original ablation procedure.

Potential risks and benefits

Since this study doesn't involve new treatments, the direct risks are very low. The main commitment is attending follow-up appointments and completing tests like the Holter monitor and questionnaires. The potential benefit for you as a participant is knowing that your contribution helps doctors understand the best long-term treatments for atrial fibrillation, which could improve care for many people in the future. You always have the right to withdraw from the study at any time without explaining why, and it will not affect your medical care.

Locations (13)

CHU Lyon, Hôpital Louis Pradel
Verified postcode
Bron, France· Not yet recruiting
Pôle Santé République
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
Hôpital Saint Philibert
Verified postcode
Lomme, France· Not yet recruiting
Hôpital Saint-Joseph Marseille
Verified postcode
Marseille, France· Recruiting
Hôpital Privé Jacques Cartier
Verified postcode
Massy, France· Not yet recruiting
Hôpital Privé du Confluent
Verified postcode
Nantes, France· Not yet recruiting
Polyclinique Saint George
Verified postcode
Nice, France· Not yet recruiting
Centre Cardiologique du Nord
Verified postcode
Saint-Denis, France· Not yet recruiting
Clinique Rhéna
Verified postcode
Strasbourg, France· Not yet recruiting
Clinique Pasteur
Verified postcode
Toulouse, France· Not yet recruiting
CHRU Nancy, Institut Lorrain du coeur et des vaisseaux
Verified postcode
Vandœuvre-lès-Nancy, France· Not yet recruiting
Klinikum Coburg
Verified postcode
Coburg, Germany· Not yet recruiting

Common questions

What is atrial fibrillation (AF)?

It's a type of irregular and often very fast heartbeat that can feel like a fluttering or pounding in your chest.

What is 'ablation'?

A medical procedure that creates tiny scars in the heart to block faulty electrical signals causing AF and help restore a normal heart rhythm.

Will I receive any new treatment in this study?

No, this study is a follow-up. You won't receive new treatments specifically for the study. It only monitors how you're doing after your previous ablation.

How long will I be in the study?

You'll be followed up for up to five years from your original ablation procedure, attending annual check-ups.

What does a 'Holter monitor' do?

It's a small, portable device you wear that records your heart's electrical activity continuously, usually for 24 hours, to detect any irregular beats.

How to find out more

Paola MILPIED

paola.milpied@volta-medical.com (0)768025499 Official trial record

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