Clinical trial NCT06825104: Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Official title: Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Artificial Intelligence
VX1
Volta AF-Xplorer
Medical Device
Cardiac Dispersion
Volta Medical
Software
Lead sponsor: Volta Medical
Sponsor class: INDUSTRY
First posted: 2025-02-13
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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previously enrolled in TAILORED-AF study, treated for their persistent AF by an index ablation procedure and not withdrawn during the 12-month follow-up period post-index procedure.

Brief 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 combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure
timeFrame: 60 months
Secondary outcomes:
measure: Long-term freedom from documented AF/AT after one or two ablation procedures
timeFrame: 60 months
measure: Long-term freedom from documented AF/AT after one ablation procedure
timeFrame: 60 months
measure: Heath Economics - Average Number of Ablation Procedures per patient
timeFrame: 60 months
measure: Heath Economics - Average Number of Hospitalizations per patient
timeFrame: 60 months
measure: Heath Economics - Average Number of Cardioversions per patient
timeFrame: 60 months
measure: Heath Economics - Quality of Life Progression (AFEQT Score)
timeFrame: 60 months
measure: Heath Economics - Quality of Life Progression (SF-36 Score)
timeFrame: 60 months
measure: Heath Economics - Proportion of Patients Under AAD
timeFrame: 60 months
measure: Incidence of complications (safety composite endpoint)
timeFrame: 60 months
Other outcomes:
Locations:
city: Bron
country: France
facility: CHU Lyon, Hôpital Louis Pradel
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Lomme
country: France
facility: Hôpital Saint Philibert
city: Marseille
country: France
facility: Hôpital Saint-Joseph Marseille
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nice
country: France
facility: Polyclinique Saint George
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Strasbourg
country: France
facility: Clinique Rhéna
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy, Institut Lorrain du coeur et des vaisseaux
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Munich
country: Germany
facility: German Heart Center
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Isabel DEISENHOFER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.