跳至主要内容
临床试验/NCT01761188
NCT01761188Unknown不适用

The Study of CPVI Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm (STABLE-SR) for the Treatment of Persistent Atrial Fibrillation

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
220
试验地点
1
主要终点
Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs).

研究概览

简要总结

  • Background:the ablation outcomes for the treatment of persistent atrial fibrillation are not as satisfactory as paroxsymal AF. The successful rate ranges from 30%-55%. We found a new novel strategy for the modification of LA substrate during sinus rhythm based on our pilot study.
  • Hypothesis: our new method may be more effective than conventional strategy.
  • Objectives:The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with persistent AF:Study Group: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR);Control Group: conventional stepwise approach for persistent AF(CPVI + Lines +CFE) .The secondary objectives of this investigation are to evaluate and compare the safety and procedural characteristics of both groups.
  • Sample size: 220
  • Time line: 2013 Q1-2014 Q2

详细描述

what's is STABLE-SR approach? In our center, the LA substrate mapping was performed in patients with paroxysmal AF and persistent AF during sinus rhythm, particularly 20 normal subjects as control group as well. Our study showed that along with the duration of AF the average voltage of LA deceased and the area of low voltage zone increased. The whole activation time of entire LA would be longer. More complex fractionated electrograms was found in LA. Importantly, we identified the low voltage zone (voltage range: 0.1-0.4mV) and the transitional zone (voltage range: 0.4-1.3mV) in which most of complex fractionated electrograms located. Based on our findings a new novel ablation strategy has emerged, which is modification of LA substrate during sinus rhythm (CPVI+STABLE-SR). Our sequential protocol included 5 steps. First CPVI should be completed followed by CTI ablation to be blocked. Then if AF rhythm maintained cardioversion would be taken. High density mapping of LA substrate would be done during sinus rhythm to identify the low voltage zone and transitional zone. Linear ablation or/and spot ablation should be designed according to the mapping results. Finally bidirectional conduction block should be demonstrated for all the linear lesion and all pulmonary veins would be checked for isolation.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing a first-time ablation procedure for AF;
  • Patients with persistent or long-lasting AF; Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years.
  • Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
  • Patients with atrial fibrillation will to accept the procedure of ablation.
  • Patients signed the written informed consent for the study.
  • Patients can endure the required follow up.

排除标准

  • Patients with paroxysmal AF; Paroxysmal AF will be defined as a sustained episode lasting < 7days.
  • Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
  • Patients with thromboemboli in LAA.
  • Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view).
  • Patients allergic for contrast or iodine.
  • Patients with the SCr >3.5mg/dl or Ccr < 30 ml/min
  • Patients with life expectancy < 12 months
  • Patients who are in the period of pregnant

结局指标

主要结局

Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs).

时间窗: 1 year after a single-ablation procedure

AF and/or AT occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any symptomatic or asymptomatic AF or AT episode that lasted for more than 30 seconds was categorized as a recurrence.

次要结局

  • total procedure time(1 year)
  • fluoroscopy time(1 year)
  • complications(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gang Yang

Doctor of Cardiology Department

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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