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临床试验/NCT03759912
NCT03759912终止不适用

The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
75
试验地点
1
主要终点
Atrial arrhythmia recurrence

研究概览

简要总结

The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.

The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.

In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age over 20 years old and under 80 years old
  • Patients with non-valvular paroxysmal atrial fibrillation
  • Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
  • Patients who could have informed consent
  • Patients who are available for a follow-up of more than at least three months after the catheter ablation

排除标准

  • Patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease
  • Patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation
  • Patients in the subject group vulnerable to a clinical study
  • Patients who had undergone a prior catheter ablation for atrial fibrillation

结局指标

主要结局

Atrial arrhythmia recurrence

时间窗: one year

recurrence of atrial tachyarrhythmia after the index procedure

次要结局

  • acute pulmonary vein reconnection rate(During procedure)
  • acute pulmonary vein isolation rate(During procedure)
  • percentage of ablation area in the antrum(During procedure)
  • Procedural outcome(During procedure)

研究者

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

Seongwook Han

Professor

Keimyung University Dongsan Medical Center

研究点 (1)

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