ECG-I Targeted Ablation for Persistent AF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Persistent AF (i.e. episodes of AF that are continuous for > 1 week)
- •Willing for ablation.
- •Age between 18 to 80.
排除标准
- •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
结局指标
主要结局
Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months
时间窗: 12 months
Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months
次要结局
- Number of participants free from Atrial Fibrillation at 12 months(12 months)
- Termination of AF with PVI followed by ECGI guided driver 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(During Catheter Ablation Procedure)