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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Volta AF-Xplorer
  Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms
• Процедура Dispersion ablation + PVI
  TAILORED-AF index procedure: Dispersion ablation + PVI
• Процедура PVI
  TAILORED-AF index procedure: PVI only

Первичные конечные точки

• Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure [Срок оценки: 60 months]

Вторичные конечные точки (9)

• Long-term freedom from documented AF/AT after one or two ablation procedures [Срок оценки: 60 months]
• Long-term freedom from documented AF/AT after one ablation procedure [Срок оценки: 60 months]
• Heath Economics - Average Number of Ablation Procedures per patient [Срок оценки: 60 months]
• Heath Economics - Average Number of Hospitalizations per patient [Срок оценки: 60 months]
• Heath Economics - Average Number of Cardioversions per patient [Срок оценки: 60 months]
• Heath Economics - Quality of Life Progression (AFEQT Score) [Срок оценки: 60 months]
• Heath Economics - Quality of Life Progression (SF-36 Score) [Срок оценки: 60 months]
• Heath Economics - Proportion of Patients Under AAD [Срок оценки: 60 months]
• Incidence of complications (safety composite endpoint) [Срок оценки: 60 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 11 центров

• CHU Lyon, Hôpital Louis Pradel — Bron
• Pôle Santé République — Clermont-Ferrand
• Hôpital Saint Philibert — Lomme
• Hôpital Saint-Joseph Marseille — Marseille
• Hôpital Privé Jacques Cartier — Massy
• Hôpital Privé du Confluent — Nantes
• Polyclinique Saint George — Nice
• Centre Cardiologique du Nord — Saint-Denis
• … и ещё 3 центра

Германия · 2 центра

• Klinikum Coburg — Coburg
• German Heart Center — Munich

Публикации

• 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 fibrillatio PMID 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. PMID 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 Electrophy PMID 35989543

Идентификаторы

NCT: NCT06825104 · CLIPL-01-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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