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临床试验/NCT03190395
NCT03190395Unknown不适用

Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation,Prospective Randomised Study

Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Maintenance time of sinus rhythm

研究概览

简要总结

Atrial fibrillation (AF) is the most serious atrial electrical activity disorders, is also one of the common tachyarrhythmias.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

详细描述

Atrial fibrillation (AF) refers to the orderly loss of atrial electrical activity, replaced by rapid and disorderly atrial fibrillation wave, is the most acute atrial electrical activity disorders, is also one of the common tachyarrhythmias. So far, the mechanism of atrial fibrillation has not yet been completely clarified. At present, there are various mechanisms to participate in the occurrence and maintenance of atrial fibrillation, which mainly involves two aspects. One is the triggering factor of atrial fibrillation, and the other is the occurrence and maintenance of atrial fibrillation (substrate). Trigger factors are varied, including sympathetic and parasympathetic stimulation, bradycardia, atrial premature beats or tachycardia, atrioventricular bypass and acute atrial pull, etc, which pulmonary vein electrical activity triggered the most common, but also is an most important theoretical Basis for the Radiofrequency Catheter Ablation of Atrial Fibrillation . Substrate is a necessary condition for the onset and maintenance of atrial fibrillation. Electrical remodeling and structural remodeling are by shortening the atrial effective refractory period. Atrial dilatation and atrial fibrosis play a major role in the formation of atrial fibrillation reentry.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1)Patients between 18-80 year-old with paroxysmal atrial fibrillation have radio frequency ablation operation indication and are willing to require AF ablation therapy.
  • (2)Voluntary consent of informed consent (3)No AF Ablation history before admission

排除标准

  • (1) Permanent or persistent AF (2) The diameter of left atrium >50mm (3) Previous AF/AFL/AT Radio Frequency Ablation (4) Congenital heart disease and/or Cardiac Surgical procedures (5) AF with rheumatic valvular disease (6) LV ejection fraction <45% (7) Intracardiac thrombi

研究组 & 干预措施

CPVI Group

Experimental

CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI)

干预措施: CPVI Group (Procedure)

CPVI+LARA Group

Active Comparator

CPVI+LARA Group: Circumferential pulmonary vein isolation combine with Left Atrium Roofline Ablation

干预措施: CPVI+LARA Group (Procedure)

结局指标

主要结局

Maintenance time of sinus rhythm

时间窗: The two groups will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation

To evaluate the effectiveness of the ablation operation, we will observe how long will these patients keep sinus rhythm after operation.

次要结局

  • The Left Ventricular Ejection Fraction(Patients's LV ejection fraction will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation)
  • The size of the left atrium(Patients's size of the left atrium will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation)

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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