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临床试验/NCT04466358
NCT04466358已完成不适用

Comparison of CLOSE Guided and High Density Mapping Guided Catheter Ablation of Paroxysmal Atrial Fibrillation

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Recurrence of atrial fibrillation

研究概览

简要总结

The aim of this study is to compare two methods of catheter ablation for treatment of paroxysmal atrial fibrillation (AF). The first method being a modified CLOSE protocol used for the control group and the second high density mapping guided isolation of pulmonary veins used for the interventional group. Comparison will be made according to clinical parameters and also durability of pulmonary vein isolation.

详细描述

CLOSE protocol is among the latest methods of catheter ablation of AF. According to this protocol, ablations are guided by ablation index, which takes into account ablation time, the contact force and power supplied by the ablation catheter. In this protocol the distance between individual ablation lesions is less than 6 millimeters (mm), thus ensuring the continuity of the ablation line around the pulmonary veins. After ablation, the electrical isolation of pulmonary veins (entry and exit block) is checked with a multi-electrode circumferential catheter. The electrical inactivity of the ablation line itself is thus checked indirectly via the conduction block. According to recent studies, the success rate of catheter ablation with this protocol after one procedure at one year is approximately 90%. Investigators believe that the presence of electrical activity within the ablation line, which does not translate into and out of the pulmonary veins during the procedure and is not detected by the currently used mapping technique, significantly affects the subsequent clinical success of the procedure. Investigators assume that high-resolution mapping of the ablation line would identify areas of electrical activity within the ablation line (dormant conduction) and that the ablation of these areas during the first procedure would significantly affect both the long-term isolation of the pulmonary veins and the clinical success of the procedure.

The aim of this study is to compare long-term clinical efficacy and efficacy of pulmonary vein isolation of two different methods of catheter ablation for treatment of AF. Participants will be randomised into two groups. In the first group isolation of pulmonary veins will be performed following a modified CLOSE protocol, the isolation will be checked with multipolar circumferential catheter. In the second group the ablation will be performed with the same method but the isolation of pulmonary veins will be checked with high-resolution mapping looking for dormant conduction in the pulmonary vein antra.

Hypothesis:

investigators expect that the incidence of the recurrence od AF in the high resolution mapping group will be lower during clinical follow-up. Investigators also expect that durable pulmonary vein isolation will be present in higher proportion of participants where high resolution mapping was performed.

Study protocol:

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

  • electrocardiographic evidence of paroxysmal AF in the last six months,
  • unsuccessful treatment with antiarrhythmic drugs or highly symptomatic arrhythmia episodes (EHRA 3 and 4).

排除标准

  • age over 80 years,
  • greatly enlarged left atrium (ultrasound parasternal diameter more than 50 mm),
  • life expectancy less than one year,
  • acute life-threatening disease,
  • previous heart surgery,
  • severe left or right ventricular dysfunction (LVEF equal or less than 35 %),
  • severe valve failure,
  • presence of a clot in the left atrium,
  • previous atrial fibrillation ablation

结局指标

主要结局

Recurrence of atrial fibrillation

时间窗: 3-12 months

Atrial fibrillation recorded with 12-lead ECG, event monitor or a 30 seconds episode recorded with Holter ECG.

Durability of pulmonary vein isolation

时间窗: 12 months

Presence of gaps in the circumferential ablation line (reconduction of pulmonary veins) as evidenced at predefined remapping procedure.

次要结局

  • Characteristics of gaps in ablation lines(0-12 months)

研究者

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

Matevz Jan

Principal investigator

University Medical Centre Ljubljana

研究点 (2)

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