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Atrial FibrillationTAILORED-LTNCT06825104

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

An observational study of Atrial Fibrillation, run by Volta Medical at 13 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Volta AF-Xplorer, Dispersion ablation + PVI and PVI
How many people
278 participants
Where
13 sitesin 2 countries
Study dates
6 Mar 2025to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients previously enrolled in TAILORED-AF study, treated for their persistent AF by an index ablation procedure and not withdrawn during the 12-month follow-up period post-index procedure.

Who may be able to join

  • Patient who participated in the Tailored AF study
  • Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study
  • Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study

Who cannot join

  • Person deprived of liberty or under guardianship
  • Person unable to undergo a medical monitoring for geographical, social or psychological reasons

Trial locations and contacts

13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Paola MILPIED contact

(0)768025499 ext. 0033

paola.milpied@volta-medical.com

Cecile BIELMANN contact

cecile.bielmann@volta-medical.com

13 sites in 2 countries

France11 sites, 11 recruiting

  • CHU Lyon, Hôpital Louis Pradel

    Bron, 69677

    Francis Bessière, MD

    Not yet recruiting

  • Pôle Santé République

    Clermont-Ferrand, 63050

    Antoine Roux, MD

    Not yet recruiting

  • Hôpital Saint Philibert

    Lomme, 59462

    Yves Guyomar, MD

    Not yet recruiting

  • Hôpital Saint-Joseph Marseille

    Marseille, 13008

    Edouard Gitenay, MD

    Recruiting

  • Hôpital Privé Jacques Cartier

    Massy, 91300

    Jérôme Horvilleur, MD

    Not yet recruiting

  • Hôpital Privé du Confluent

    Nantes, 44277

    Sélim Abbey, MD

    Not yet recruiting

  • Polyclinique Saint George

    Nice, 06105

    Guillaume Théodore, MD

    Not yet recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 93207

    Antoine Lepillier, MD

    Not yet recruiting

  • Clinique Rhéna

    Strasbourg, 67000

    Babé Bakouboula, MD

    Not yet recruiting

  • Clinique Pasteur

    Toulouse, 31076

    Jean-Paul Albenque, MD

    Not yet recruiting

  • CHRU Nancy, Institut Lorrain du coeur et des vaisseaux

    Vandœuvre-lès-Nancy, 54500

    Christian De Chillou, MD

    Not yet recruiting

Other trials in France

Germany2 sites, 2 recruiting

  • Klinikum Coburg

    Coburg, 96450

    Mathias Forkmann, MD

    Not yet recruiting

  • German Heart Center

    Munich, 80636

    Isabel Deisenhofer, MD

    Not yet recruiting

Other trials in Germany

About this study

The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.

Read the detailed description

The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF).

VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm.

No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study.

The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively.

The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

Being tested
Volta AF-Xplorer, Dispersion ablation + PVI, PVI
Keywords
Artificial Intelligence, VX1, Volta AF-Xplorer, Medical Device, Cardiac Dispersion, Volta Medical, Software
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volta AF-XplorerDevice

    Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms

  • Dispersion ablation + PVIProcedure or surgery

    TAILORED-AF index procedure: Dispersion ablation + PVI

  • PVIProcedure or surgery

    TAILORED-AF index procedure: PVI only

Study groups in NCT06825104
Study groupRoleWhat they receive
Experimental: TailoredPatients from the "Tailored" group in the initial study TAILORED-AF. Patients in this group underwent "Tailored" AF ablation, i.e. the analysis and targeting of pathological areas using Volta Medical's artificial intelligence software (Volta AF-Xplorer, formerly VX1), in addition to electrical isolation of the pulmonary veins (PVI).
Receives: Device: Volta AF-Xplorer; Procedure: Dispersion ablation + PVI
Active Comparator: AnatomicalPatients from the "Anatomical" group in the initial study TAILORED-AF. Patients in this group underwent PVI only.
Receives: Procedure: PVI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure

    Long-term freedom from documented AF episodes > 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure.

    Measured: 60 months

Secondary outcomes (9)

  1. Long-term freedom from documented AF/AT after one or two ablation procedures

    Long-term freedom from documented AF and Atrial Tachycardia (AT) episodes > 30 seconds, after one or two procedures, with or without AADs

    Measured: 60 months

  2. Long-term freedom from documented AF/AT after one ablation procedure

    Long-term freedom from documented AF/AT episodes > 30 seconds, after one procedure, with or without AADs

    Measured: 60 months

  3. Heath Economics - Average Number of Ablation Procedures per patient

    To determine how the number of repeat ablation procedures in addition to the index procedure impacts health care costs.

    Measured: 60 months

  4. Heath Economics - Average Number of Hospitalizations per patient

    To determine how the number of hospitalizations post-ablation index procedure impacts health care costs.

    Measured: 60 months

  5. Heath Economics - Average Number of Cardioversions per patient

    To determine how the number of cardioversions post-ablation index procedure affects health care costs.

    Measured: 60 months

  6. Heath Economics - Quality of Life Progression (AFEQT Score)

    To determine how the quality of life progression after the ablation index procedure (measured with the Atrial Fibrillation Effect on Quality of Life Questionnaire AFEQT) impacts health care costs.

    AFEQT score ranges from 0 to 100, with higher scores indicating better quality of life.

    Measured: 60 months

  7. Heath Economics - Quality of Life Progression (SF-36 Score)

    To determine how the Quality of life progression after the ablation index procedure (measured with the 36-Item Short Form Health Survey SF-36) impacts health care costs.

    The SF-36 consists of eight domains measuring physical and mental health, with scores ranging from 0 to 100 (higher scores indicate better quality of life).

    Measured: 60 months

  8. Heath Economics - Proportion of Patients Under AAD

    To determine how the proportion of patients under antiarrhythmic drugs (AAD) impacts health care costs.

    Measured: 60 months

  9. Incidence of complications (safety composite endpoint)

    Incidence of complications: death, cerebrovascular events, or serious treatment-related adverse event at long-term.

    NOTE: In addition, each component of the composite endpoint will be individually assessed.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start6 Mar 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
278 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06825104
Sponsor's protocol ID
CLIPL-01-006
Acronym
TAILORED-LT
Status last verified
Mar 2025
First submitted
31 Jan 2025
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deisenhofer I, Albenque JP, Busch S, Gitenay E, Mountantonakis SE, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Jan Smit J, Mohr Durdez T, Milpied P, Appetiti A, Guerrero D, De Potter T, De Chillou C, Goldbarg S, Verma A, Hummel JD; TAILORED-AF Investigators. Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial. Nat Med. 2025 Apr;31(4):1286-1293. doi: 10.1038/s41591-025-03517-w. Epub 2025 Feb 14.

    PubMed 39953289

  • Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

    PubMed 28104073

  • Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.

    PubMed 35989543

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Volta Medical at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paola MILPIED ((0)768025499 ext. 0033, paola.milpied@volta-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06825104, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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