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临床试验/NCT04085731
NCT04085731招募中不适用

Driver-guided Ablation in the Treatment of Persistent Atrial Fibrillation

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2019年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
181
试验地点
1
主要终点
Freedom from any AF or atrial tachycardia assessed from the end of the months blanking period to 12 months after ablation.

研究概览

简要总结

This is a prospective, single-center, study. A targeted number of 181patients with persistent AF will be included according to pre-defined criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated mapping technique. We hypothesize that such approach may potentially lead to a mechanisms-targeted ablation strategy of persistent AF.

详细描述

This is a prospective, single-center, study enrolling a total of 181patients with persistent AF according to well defined inclusion and exclusion criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated 3D mapping technique followed by standard CPVA at the end of the procedure. We will ablate substrates showing fast and regular electrical activities, starting from areas with the fastest mean cycle length and/or areas that have consistent rotational or focal propagation pattern and/or areas that comprise the slow conduction zone of possible arrhythmia circuits. After substrate ablation and AF termination, arrhythmia inducibility will be assessed and, if not inducible, the procedure will be completed by standard CPVA. If AF is still inducible, a new 3D map will be performed to identify further targets to be eliminated. Electrical cardioversion may be done at the end of the procedure. We hypothesized that such approach may potentially lead to a mechanisms-targeted ablation strategy leading to elimination of arrhythmic sources in individual patients, thus improving their clinical outcome. We will also characterize, identify and target the real pathophysiological substrates. After ablation, AF recurrence will be assessed by implantable loop recorder or thans-telephonic ECG recording from the end of the 3 months blanking period to 12 months following the procedure.The duration of this study is expected to be 24 months, from the first patient enrollment to the last patient follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age (18-85 years), persistent AF according to ESC/EHRA guidelines, first or second ablation procedure, ability to provide informed written consent.

排除标准

  • Secondary AF, Hyperthyroidism, LVEF<30%, NYHA functional class IV, uncorrected valvular heart diseases, contraindication to anticoagulation, left atrial thrombus, recent (<6 months) myocardial infarction, thoracic surgery for congenital, valvular diseases, History of cerebrovascular events, pregnancy, cancer or other significant comorbidities.

结局指标

主要结局

Freedom from any AF or atrial tachycardia assessed from the end of the months blanking period to 12 months after ablation.

时间窗: 12 months after ablation

AF recurrences will be documented by implantable loop recorder or trns-telephonic ECG recording

次要结局

  • inducibility of AF after the procedure(during the procedure)
  • AF burden(12 months after ablation)
  • Identification of electrophysiological substrate(during the procedure)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Pappone

Director

IRCCS Policlinico S. Donato

研究点 (1)

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