跳至主要内容
临床试验/NCT02477592
NCT02477592Unknown不适用

A Prospective Randomized Study of a Novel Individualized Substrate Modification Approach Versus Stepwise Ablation for the Treatment of Long-standing Persistent Atrial Fibrillation

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
220
试验地点
1
主要终点
atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation

研究概览

简要总结

The purpose of this study is to compare effectiveness of two substrate modification approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a substrate-based, individualized substrate modification (ISM)approach should be superior to traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the first study to evaluate the "real" substrate by means of electro-anatomic mapping and to perform "true" substrate modification in long standing persistent atrial fibrillation ablation(LPAF).

详细描述

Catheter ablation (CA) is highly effective for paroxysmal atrial fibrillation(AF), it is modestly effective for long standing persistent atrial fibrillation ablation(LPAF) even with complex or combined approaches, which is mainly attributed to the substrate underlying AF remodeling. Severity of atrial fibrosis is closely associated with clinical outcomes after CA for AF . The more atrial scars and fibrosis present, the lower the success rate for AF ablation. Patients with LPAF have many more areas with scars and fibrosis than those with paroxysmal AF or non-AF controls. The MRI delayed enhancement technique provides a non-interventional tool for evaluation of atrial fibrosis, however, it must be performed in sinus rhythm.Three-dimensional electro anatomic mapping has proven as accurate as MRI and can be performed easily during AF ablation, thus providing a good tool for evaluation of atrial substrate during LPAF ablation.

Although electro-anatomic mapping provided a desirable surrogate for delayed enhancement MRI to define AF substrate, there was an important technical issue to be considered. There were no good techniques to predict a desirable tip-tissue contact before the contact force catheter was applied. A poor tip-tissue contact could render the results of voltage mapping less reliable. On the other hand, excessively high contact force could increase the risk of steam pop and cardiac perforation during ablation. Hence it was important to use the contact force catheter to perform substrate mapping and ablation.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 and ≤ 72years
  • •History of LPAF for ≥1 and ≤ 5 years
  • •Written informed consent provided
  • •Acceptance of catheter ablation treatment
  • •Acceptance of post-ablation follow-up

排除标准

  • •Prior history of catheter ablation or surgical ablation
  • •Abnormal coagulation; contraindication for anti-coagulation
  • •left atrium diameter ≥ 55mm
  • •left atrium thrombus

研究组 & 干预措施

Individualized substrate modification

Experimental

Circumferential pulmonary vein isolation(CPVI) ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by Individualized substrate modification.

干预措施: individualized substrate modification (Procedure)

Stepwise ablation

Active Comparator

CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.

干预措施: stepwise ablation (Procedure)

结局指标

主要结局

atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation

时间窗: 1 year

次要结局

  • Fluoroscopy exposure time(1 year)
  • Prevalence of recurrent atrial flutter(1 year)
  • Proportion of pulmonary vein isolation(1 year)
  • Proportion of acute pulmonary vein re-connection(1 year)
  • Total ablation time(1 year)
  • Number of participants with adverse event(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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