Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 13
- 主要终点
- Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Person deprived of liberty or under guardianship
- •Person unable to undergo a medical monitoring for geographical, social or psychological reasons
结局指标
主要结局
Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure
时间窗: 60 months
Long-term freedom from documented AF episodes \> 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure.
次要结局
- Long-term freedom from documented AF/AT after one or two ablation procedures(60 months)
- Long-term freedom from documented AF/AT after one ablation procedure(60 months)
- Heath Economics - Average Number of Ablation Procedures per patient(60 months)
- Heath Economics - Average Number of Hospitalizations per patient(60 months)
- Heath Economics - Average Number of Cardioversions per patient(60 months)
- Heath Economics - Quality of Life Progression (AFEQT Score)(60 months)
- Heath Economics - Quality of Life Progression (SF-36 Score)(60 months)
- Heath Economics - Proportion of Patients Under AAD(60 months)
- Incidence of complications (safety composite endpoint)(60 months)