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ECG-I Targeted Ablation for Persistent AF (TARGET-AF)

2020年11月11日 更新者:Barts & The London NHS Trust

Atrial fibrillation (AF) is an irregular heart rhythm associated with significant morbidity and mortality. Catheter ablation is an established treatment where catheters are inserted through a vein in the leg into the left atrium of the heart to deliver lines of scar to disrupt the tissue causing and maintaining AF.

The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located.

Success rates for persistent atrial fibrillation lie in the region of 30-60% due to the location of drivers (tissue causing and maintaining AF) varying per patient. Locating and treating these drivers is very challenging.

We intend to enrol 40 patients with persistent AF and perform atrial mapping using the ECG-I system. We will perform pulmonary vein isolation and perform atrial mapping to identify the location of these drivers and then to ablate them. We will study the effects of performing ablation upon these drivers using the ECG-I.

研究概览

详细说明

Atrial Fibrillation (AF) is the commonest heart rhythm disturbance and is associated with significant morbidity and mortality. Catheter ablation (CA) is a procedure where catheters (leads) are passed into the heart and energy is used to disrupt and isolate (by freezing or cauterising) heart tissue causing AF. CA is an established therapy for AF. Success rates for CA for paroxysmal AF lies in the region of 70% or better. However, success rates for persistent AF is much lower and estimates lie in the region of 30-60%.

Current CA protocols for AF centre on isolating the pulmonary veins (the pulmonary veins drain into the left atrium) which have been proven to trigger AF. Pulmonary Vein Isolation (PVI) ablation alone seems sufficient to remove the trigger for the vast majority of patients with paroxysmal AF. However, in patients with persistent AF it is common for AF to continue after the pulmonary veins have been electrically isolated.

The difference in success rates between the paroxysmal and persistent form of AF is thought to be due to changes within the heart atria after AF has been established for some time. In persistent AF the atria dilate and remodel structurally and electrically, and therefore the maintenance of persistent AF differs from paroxysmal AF.

Persistent AF is thought to be maintained by focal sources, whether rotors or sites of radial activation. Currently, targeting other sites within the atria in addition to PVI such as fractionated electrograms (areas of electrical activity) are thought to be imprecise and require extensive ablation. Often AF will persist despite targeting additional sites within the atria.

Currently clinical characteristics of patients or structural imaging have limited accuracy in selecting patients likely to benefit from CA. Mapping studies have shown that patients with persistent AF who have higher frequency signals near the pulmonary veins than being distributed in the left atrial body are more likely to terminate to sinus rhythm (normal heart rhythm) with PVI alone and to maintain sinus rhythm.

Studies have suggested that patients undergoing standard PVI ablation procedures for persistent AF who have coincidental interruption of drivers have a far better long term outcome. This suggests that the characteristics of atrial heart tissue and electrical activation patterns maintaining AF are likely to determine the response to ablation therefore it may be possible to determine more directly and accurately the likelihood of success by performing non-invasive mapping of the atria using the ECG-I.

ECG-I is able to localise the drivers of AF and one of the objectives is to study the electrical characteristics of the tissue. ECG-I is currently being used in research into AF. A recently published a study using ECG-I to identify targets of ablation in 103 patients. They suggested that using ECG-I may improve CA success rates and reduces the procedure time and amount of ablation. The prospective multicentre AFACART study had similar findings.

We intend to enrol 40 patients who will undergo Atrial Mapping with ECG-I during catheter ablation. After isolation of the pulmonary veins patients drivers will be targeted guided by the system.

研究类型

介入性

注册 (实际的)

40

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。

学习地点

      • London、英国、EC1A 7BE
        • Barts Heart Centre

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

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Persistent AF (i.e. episodes of AF that are continuous for > 1 week)
  • Willing for ablation.
  • Age between 18 to 80.

Exclusion Criteria:

  • Duration of continuous persistent AF > 2 years
  • Left atrial diameter > 5 cm
  • Severe left ventricular impairment (EF < 40%)
  • New York Heart Association class 3 or 4 heart failure
  • Known hypertrophic cardiomyopathy, cardiac sarcoid or Arrhythmogenic cardiomyopathy.
  • Known inherited arrhythmia such as Brugada or long QT syndromes
  • Valvular disease that is more than moderate
  • History of valve replacement (metallic or tissue)
  • History of congenital heart disease (other than patent foramen ovale)
  • Previous left atrial ablation (percutaneous or surgical)
  • Cardiac surgery or percutaneous coronary intervention within the last 3 months.
  • Myocardial infarction or unstable angina within the last 3 months.
  • Unwillingness for ablation
  • Unwillingness to be involved in study
  • Suspected reversible cause of AF
  • Any other contraindication to catheter ablation
  • Age < 18 yrs or > 80 years
  • Pregnancy
  • Morbid obesity (defined as body mass index >40)
  • Any other medical problem likely to cause death within the next 18 months

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:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 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:PVI followed by targeting of drivers
Patients will undergo intra-procedural mapping using the ECG-I. The pulmonary veins will be isolated. Drivers will then be targeted as guided by the ECG-I system aiming for termination of AF.
Patients will undergo intraprocedural ECG-I mapping. The pulmonary veins will be isolated followed by targeting of drivers aiming to terminate AF.

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
Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months
大体时间:12 months
Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months
12 months

次要结果测量

结果测量
措施说明
大体时间
Number of participants free from Atrial Fibrillation at 12 months
大体时间:12 months
Number of participants free from Atrial Fibrillation at 12 months.
12 months
Termination of AF with PVI followed by ECGI guided driver ablation
大体时间:During Catheter Ablation Procedure
Rates of termination of AF intra-procedurally during ablation
During Catheter Ablation Procedure
Composite end point including rates of AF termination and cycle length slowing with PVI followed by ECGI guided driver ablation
大体时间:During Catheter Ablation Procedure
Rates of reaching composite end point (either termination of AF or cycle length slowing) intra-procedurally during ablation
During Catheter Ablation Procedure

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:Ross Hunter、Barts Heart Centre

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1月1日

初级完成 (预期的)

2021年3月31日

研究完成 (预期的)

2021年6月1日

研究注册日期

首次提交

2020年11月11日

首先提交符合 QC 标准的

2020年11月11日

首次发布 (实际的)

2020年11月17日

研究记录更新

最后更新发布 (实际的)

2020年11月17日

上次提交的符合 QC 标准的更新

2020年11月11日

最后验证

2020年11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)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

是的

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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