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临床试验/NCT04045067
NCT04045067已完成不适用

Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation

French Cardiology Society9 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2019年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
212
试验地点
9
主要终点
Evaluation of the success rate of the procedures

研究概览

简要总结

This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

详细描述

Radiofrequency ablation has become standard practice in the approach strategy for the symptomatic treatment of atrial fibrillation. The interest of substrate ablation, completing the isolation of the pulmonary veins is controversial. The usual technique for the ablation of recurrent atrial fibrillation is primarily a disconnection of the pulmonary veins, which can be accomplished by isolating the veins one by one or two by two. The isolation of the pulmonary veins is followed most often by a defragmentation of the atrium (ablation of the substrate). The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. This strategy requires extensive ablation of the left atrium, with a long procedure time and repeated many radiofrequency shots. On the one hand there is a risk of complication related to the duration of intervention, but also in the longer term of occurrence of flutter scar. In addition to pulmonary vein isolation, the goal is to identify patients with sinus rhythm atrial arrhythmogenic substrate. Once the sinus rhythm has been restored by electrical cardioversion or spontaneously, a voltage map is carried out to identify the most abnormal (low voltage) areas, and intra-atrial fragmented potentials are identified, either spontaneously or spontaneously by the extra-stimulus method. Ablation of these abnormal areas may lead to better long-term results, limiting prolonged radiofrequency shots and complications associated with longer procedure times.

研究设计

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

入排标准

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

入选标准

  • Patients with persistent atrial fibrillation ablation, no specific indication restrictions or equipment used and regardless of the outcome of the procedure
  • Patients participating in a biomedical research can participate in this study.

排除标准

  • Pregnant or lactating women can not participate in this study

结局指标

主要结局

Evaluation of the success rate of the procedures

时间窗: month 18

Comparison between the 3 study arms of the number of new episodes of symptomatic atrial fibrillation

次要结局

  • Evaluation of the efficiency of the procedures(Day 1)
  • Evaluation of the safety of the procedures(Day 1 / month 3 / month 6 / month 12 / month 18)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (9)

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