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Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

2022年6月1日 更新者:Taipei Veterans General Hospital, Taiwan

A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.

研究概览

详细说明

In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.

The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.

研究类型

介入性

注册 (预期的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Taipei、台湾、112
        • 招聘中
        • Taipei General Veterans Hospital
        • 接触:
          • Yenn-Jiang Lin, MD, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patents who sign the informed consent forms, and allow to be followed.
  2. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
  3. Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
  4. Patients with age equal or greater than 20 years old regardless of gender.

Exclusion Criteria:

  1. The presence of a atrial or ventricular thrombus.
  2. Patients who are allergic to or unsuitable for use with the contrast media.
  3. Pregnant patients or patients who are unavailable to receive X-ray.
  4. Patients with renal insufficiency.
  5. Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure.
  6. Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
  7. Patients with age less than 20 years old or greater than 90 years old regardless of gender.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:肺静脉隔离+波形周期组
肺静脉隔离+基底消融
The 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module. Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.
基板修改将以波形周期性分析为指导。 波形周期分析的用户定义图也将由带有 VISITAG ODP 模块的 CARTO 3 系统(第 6 版)创建。 将使用 Pentaray 导管并促进心房基质的高密度映射(PentarayTM,Biosense Webster Inc.,Diamond Bar,CA,USA)。 将使用 7.5F、3.5-mm Thermocool SMARTTOUCH 消融导管(Biosense Webster, Inc., Diamond Bar, CA, USA)进行基于波形周期性分析的基板修改。 射频能量将以 5-25 g 的接触力范围连续施加,目标消融指数在后壁上为 380-400,在前壁上为 550-600,在功率控制模式下最大功率为 25-35W。
其他:肺静脉隔离组
肺静脉隔离(常规治疗)
The 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module. Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
房颤导管消融术后正常窦性心律保持率的变化
大体时间:基线和房颤导管消融后 3、6、9 和 12 个月

将在消融后 3、6、9 和 12 个月和/或消融后患者出现提示心动过速的症状时进行 24 小时动态心电图监测和/或心电图(7 天记录)。

测量:记录 AF 信号持续时间超过 30 秒。

基线和房颤导管消融后 3、6、9 和 12 个月

次要结果测量

结果测量
措施说明
大体时间
LAD
大体时间:after catheter ablation of atrial fibrillation 3, 6, 12 month

Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF.

LAD [left atrial diameter]

after catheter ablation of atrial fibrillation 3, 6, 12 month
LVEF
大体时间:after catheter ablation of atrial fibrillation 3, 6, 12 month

Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF.

LVEF [left ventricular ejection fraction]

after catheter ablation of atrial fibrillation 3, 6, 12 month
e/e'
大体时间:after catheter ablation of atrial fibrillation 3, 6, 12 month

Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF.

e/e'[the ratio of early diastolic mitral inflow velocity to early diastolic mitral annulus velocity]

after catheter ablation of atrial fibrillation 3, 6, 12 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yenn-Jiang Lin, MD, PhD、Director of Cardiology Division of Taipei Veterans General Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年2月19日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2025年12月31日

研究注册日期

首次提交

2022年4月1日

首先提交符合 QC 标准的

2022年4月11日

首次发布 (实际的)

2022年4月19日

研究记录更新

最后更新发布 (实际的)

2022年6月6日

上次提交的符合 QC 标准的更新

2022年6月1日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The patient's data was available to the host of IRB.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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