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临床试验/NCT02814955
NCT02814955Unknown不适用

Study of Electrophysiological Effects of NACOS and AVK on the Pulmonary Veins and the Left Atrium of Patients Referred for Paroxysmal AF Catheter Ablation

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Reccurence of atrial fibrillation

研究概览

简要总结

Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these pulmonary veins, medicated way (antiarrhythmic) or interventional. Ablation (radiofrequency or cryotherapy) has become in this context recognized and effective treatment of AF. In addition, antithrombotic treatments in this context is a major treatments for the prevention of stroke (stroke). They are most often associated with antiarrhythmic treatment to prevent recurrence of AF or to slow it during a relapse.

Recent experimental studies have highlighted the direct electrophysiological properties of dabigatran and rivaroxaban in the pulmonary veins and the left atrium. Dabigatran demonstrated in this study that it induced a prolongation of potential action in the pulmonary veins and the left atrium and it decreased the incidence of FA-induced by stimulation. Conversely, rivaroxaban induces shortening of the action potential in the left atrium (untested properties in the pulmonary veins). To our knowledge, apixaban and warfarin have not been studied in this context.

It is therefore possible that some of the new oral anticoagulants (NACOS) or some AVK (fluindione and warfarin), have direct electrophysiological effects in the pulmonary veins and on the left atrium and could influence AF recurrences (with effect " antiarrhythmic-like "or rather a pro-arrhythmic effect) after ablation.A retrospective analysis conducted at the University Hospital of Caen on very low numbers suggest that patients on dabigatran would have less pulmonary veins connected in early ablation procedure that patients on warfarin or rivaroxaban. Despite the limitations inherent in this analysis (very low numbers, retrospective analysis, unique setting and having studied his own limits), these results are consistent with the fundamental studies, and thus encourage us to pursue our hypothesis to obtain more statistical power and reliability in our measurements and results.

We therefore propose the study of the electrophysiological effects of NACOS (apixaban, dabigatran, rivaroxaban) and warfarin (warfarin and fluindione) on the pulmonary veins and the left atrium of patients referred for ablation of paroxysmal AF (radiofrequency or cryotherapy ) the CHU of Caen and Tours and clinic Saint Martin Caen.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All hospitalized patients for ablation of paroxysmal AF
  • On healthy heart
  • Sinus rhythm during the procedure
  • Patient> 18 years

排除标准

  • Patient <18 years
  • Severe Mitral valve disease,
  • underlying heart disease
  • Patients refusing to participate to the study

结局指标

主要结局

Reccurence of atrial fibrillation

时间窗: 6 months

次要结局

  • Measure of refractory period for each pulmonary veins and left atria(1 day)
  • number of active pulmonary veins(1 day)
  • Spontaneous cycle length in active pulmonary veins(1 day)
  • Number of connected pulmonary veins(1 day)
  • Number of re-connected pulmonary veins with ATP(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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