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临床试验/NCT00671905
NCT00671905已完成不适用

Circumferential vs Ganglionated Plexi Ablation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Study

Cardiovascular Research Society, Greece4 个研究点 分布在 3 个国家目标入组 150 人开始时间: 2008年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
4
主要终点
Freedom of AF or other atrial arrhythmia

研究概览

简要总结

The investigators have recently shown that anatomic ganglionated plexi (GP) ablation is inferior to circumferential pulmonary vein (PV) ablation for the treatment of paroxysmal AF. In this study, however, 26% of patients subjected to GP ablation alone without circumferential lesions were free of AF-recurrence up to one year after the ablation procedure. The investigators hypothesized that a combination of circumferential ablation with high-frequency-stimulation-identified GP ablation is superior to conventional circumferential ablation for the prevention of recurrences of paroxysmal atrial fibrillation (AF). The investigators are, therefore, conducting a randomized study comparing conventional circumferential ablation to a combination of circumferential ablation plus specific right and left atrial GP ablation in patients with drug-refractory paroxysmal AF.

详细描述

Introduction:

In clinical studies, epicardial or endocardial partial ganglionated plexi (GP) ablation may prevent AF,1-4 and parasympathetic denervation has been proposed as a potential mechanism of circumferential or antral pulmonary vein (PV) ablation for the treatment of atrial fibrillation.5,6 However, there have also been reports of a temporary only 7 or even proarrhythmic effect of this approach by means of increased vulnerability of vagally-mediated AF,8,9 or ablation-related macro-reentrant left atrial tachycardias.10 Thus, the potential contribution of GP modification to clinical success of circumferential or antral pulmonary vein ablation that unavoidably affects adjacent GP is not known. Few publications exist on isolated GP ablation with variable results in terms of eliminating paroxysmal or persistent AF.11-13 We have recently shown that anatomically-oriented regional ablation at the areas of GP is superior to selective GP ablation, following identification of GP by high-frequency stimulation, conferring success rates comparable to these of pulmonary vein (PV) isolation procedures.13 We hypothesized that GP ablation guided by both HF stimulation and anatomical orientation is superior to PV isolation in patients with paroxysmal AF. We also aimed at comparing these two approaches with a combination of GP ablation and PV isolation. We are, therefore, conducting a randomized study comparing the three techniques in patients with drug-refractory paroxysmal AF.

Methods:

Patients with symptomatic, paroxysmal AF were randomized to three groups:

Group 1. Patients are subjected to conventional PV isolation through circumferential ablation 1-2 cm from the PV ostium.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • paroxysmal AF
  • age < 75 years
  • left atrial size < 5 cm

排除标准

  • malignancies
  • LVEF < 35%

研究组 & 干预措施

1

Active Comparator

Circumferential PV isolation

干预措施: PV isolation (Procedure)

2

Active Comparator

HF stimulation-guided and anatomic ablation of the main right and left atrial GP.

干预措施: GP ablation (Procedure)

3

Active Comparator

HF stimulation-guided and anatomic ablation of the main right and left atrial GP followed by circumferential PV isolation

干预措施: GP ablation (Procedure)

3

Active Comparator

HF stimulation-guided and anatomic ablation of the main right and left atrial GP followed by circumferential PV isolation

干预措施: PV isolation (Procedure)

结局指标

主要结局

Freedom of AF or other atrial arrhythmia

时间窗: 2 years

次要结局

  • Quality of life(2 years)

研究者

发起方
Cardiovascular Research Society, Greece
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr D Katritsis

Dr Demosthenes Katritsis, MD, PhD(Lon), FRCP, FESC, FACC

Cardiovascular Research Society, Greece

研究点 (4)

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