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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Tailored | Patients 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). |
| |
| Active Comparator: Anatomical | Patients from the "Anatomical" group in the initial study TAILORED-AF. Patients in this group underwent PVI only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volta AF-Xplorer | Device | Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 months |
| Long-term freedom from documented AF/AT after one ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola MILPIED | Contact | (0)768025499 | 0033 | paola.milpied@volta-medical.com |
| Cecile BIELMANN | Contact | cecile.bielmann@volta-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Isabel DEISENHOFER, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lyon, Hôpital Louis Pradel | Not yet recruiting | Bron | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39953289 | Background | 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. | |
| 28104073 |
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| Dispersion ablation + PVI | Procedure | TAILORED-AF index procedure: Dispersion ablation + PVI |
|
| PVI | Procedure | TAILORED-AF index procedure: PVI only |
|
Long-term freedom from documented AF/AT episodes > 30 seconds, after one procedure, with or without AADs |
| 60 months |
| 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. | 60 months |
| Heath Economics - Average Number of Hospitalizations per patient | To determine how the number of hospitalizations post-ablation index procedure impacts health care costs. | 60 months |
| Heath Economics - Average Number of Cardioversions per patient | To determine how the number of cardioversions post-ablation index procedure affects health care costs. | 60 months |
| 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. | 60 months |
| 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). | 60 months |
| Heath Economics - Proportion of Patients Under AAD | To determine how the proportion of patients under antiarrhythmic drugs (AAD) impacts health care costs. | 60 months |
| 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. | 60 months |
| Pôle Santé République | Not yet recruiting | Clermont-Ferrand | 63050 | France |
|
| Hôpital Saint Philibert | Not yet recruiting | Lomme | 59462 | France |
|
| Hôpital Saint-Joseph Marseille | Recruiting | Marseille | 13008 | France |
|
| Hôpital Privé Jacques Cartier | Not yet recruiting | Massy | 91300 | France |
|
| Hôpital Privé du Confluent | Not yet recruiting | Nantes | 44277 | France |
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| Polyclinique Saint George | Not yet recruiting | Nice | 06105 | France |
|
| Centre Cardiologique du Nord | Not yet recruiting | Saint-Denis | 93207 | France |
|
| Clinique Rhéna | Not yet recruiting | Strasbourg | 67000 | France |
|
| Clinique Pasteur | Not yet recruiting | Toulouse | 31076 | France |
|
| CHRU Nancy, Institut Lorrain du coeur et des vaisseaux | Not yet recruiting | Vandœuvre-lès-Nancy | 54500 | France |
|
| Klinikum Coburg | Not yet recruiting | Coburg | 96450 | Germany |
|
| German Heart Center | Not yet recruiting | Munich | 80636 | Germany |
|
| Background |
| 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. |
| 35989543 | Background | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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