VOLta Medical AI-software in REal-World During AF Ablation

Официальное название

Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies

Обзор

This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in "real life"clinical practice, without any imposed clinical workflow.

Подробное описание

All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II) during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to standard practice. Intraoperative and postoperative follow-up will be performed as in routine clinical practice during AF ablation procedures: hospitalization for ablation procedure and standard postoperative quarterly visits (at 3 months, at 6 months and/or 9 months as per the study investigator's Standard Of Care) then annual visits up to 24 months post-ablation. Adverse Events, recurrences of atrial arrhythmia, Heart Failure related symptom score ("NYHA") and AF related symptoms (EHRA score) are collected from the patient's enrollment until the patient's study termination. A quality-of-life questionnaire related to general health (EQ-5D-3L) is collected during the preoperative visit and at least during annual follow-up visits. The patient's study-termination corresponds to the last annual visit at 24 months post-ablation index.

Вмешательства

• Устройство Cardiac mapping
  All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II, used in accordance with its approved indication as per of its IFU) during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to his standard practice. The two main phases of the ablation procedure are: * 3D mapping of the

Первичные конечные точки

• Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, at 12 and 24 months. [Срок оценки: 24 months]
• Volta AF-Xplorer II-related Serious Incident rate [Срок оценки: 24 months]
• Ablation procedure-related Serious Adverse Event rate [Срок оценки: 24 months]

Вторичные конечные точки (9)

• Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). [Срок оценки: 24 months]
• Progression of the AF related symptom score ("EHRA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). [Срок оценки: 24 months]
• Progression of the Heart Failure related symptom score ("NYHA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). [Срок оценки: 24 months]
• Hospitalization rate during the post-ablation follow-up period. [Срок оценки: 24 months]
• Serious Adverse Event rate during the post-ablation follow-up period. [Срок оценки: 24 months]
• Average number of ablation procedures per patient up to 24 months follow-up. [Срок оценки: 24 months]
• Average number of cardioversions per patient up to 24 months follow-up [Срок оценки: 24 months]
• Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study. [Срок оценки: 24 months]
• Health economics analysis including QALY metric [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patient aged 18 years or older.
• Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.
• Patient able and willing to provide written informed consent to participate in the study.
• Only for France: Patient affiliated to the French social security system.

Критерии исключения

• Contraindication to AF/AT catheter ablation using RF and/or PFA.
• Patient who is or could potentially be pregnant.
• Person deprived of liberty or under guardianship.
• Person unable to undergo a medical monitoring for geographical, social or psychological reasons.
• Patient's refusal to participate in the study.
• Enrollment in a premarket clinical study evaluating device, drug or biologic product.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 3 центра

• Hôpital Saint-Joseph Marseille — Marseille
• Centre Cardiologique du Nord — Saint-Denis
• Clinique Rhéna — Strasbourg

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
• Hummel JD, Zei PC, Metzl M, Deisenhofer I, Rashid H, Morales G, Horvilleur J, Mountantonakis S, Albenque JP, Vasaiwala S, De Potter T, Lador A, Magnano A, Chicos AB, Silverstein J, Guerrero D, Beguin S, El-Benna A, Nguyen-Tu MS, Lotteau S, Milpied P, Durdez TM, Kalifa J, Bars C, Seitz J, D'Souza B, Cooper DH, Nair D, Lakkireddy D. Reablation of atrial fibrillation targeting electrogram dispersion PMID 41638617
• Deisenhofer I, Seitz J, Nguyen-Tu MS, Lotteau S, Bars C, Albenque JP, Busch S, Gitenay E, Mountantonakis S, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Smit JJ, Rajendra A, Cooper DH, Rashid H, De Potter T, De Chillou C, Goldbarg S, Verma A, Morales G, Milpied P, Hummel JD, Kalifa J. Women with persistent atrial fibrillation need more than pu PMID 41311304
• Deisenhofer I, Seitz J, Lotteau S, Albenque JP, Busch S, Nguyen-Tu MS, Dayot A, Dalmau M, Leukovich H, Bars C, De Potter T, de Chillou C, Goldbarg S, Appetiti A, Milpied P, Durdez TM, Hummel JD, Kalifa J. Targetable atrial tachycardias after artificial intelligence-guided ablation of persistent atrial fibrillation. Heart Rhythm. 2026 Mar;23(3):e357-e367. doi: 10.1016/j.hrthm.2025.11.018. Epub 2025 PMID 41242590

Идентификаторы

NCT: NCT07621055 · CLIPL-05-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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