Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Long-term Clinical Success Rate
研究概览
简要总结
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.
详细描述
This study is a prospective, single center, randomized, single-blind, controlled, 2-arm parallel group trial in Milan, Italy.
The total duration of the study is expected to be 24 months with ~12 months of enrollment.
Approximately 80 subjects suffering from persistent AF will be randomized in a 1:1 fashion to the following investigation arms:
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Modified circumferential pulmonary vein ablation alone (mCPVA);
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Substrate-targeted ablation guided by AF substrate mapping, followed by completion of modified circumferential pulmonary vein ablation (Substrate+ mCPVA)
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Ablate the areas that have fast and regular electrical activities, starting from the fastest cycle length (defined by Mean CL in the range of 120-250 milliseconds, and SD CL in the range of 1-30 milliseconds
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Ablate the areas that have consistent rotational or focal propagation pattern (defined by conduction velocity vectors)
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Ablate the areas that comprises the slow conduction zone of possible arrhythmia circuits
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If AF terminates during RF ablation, stimulation protocol will be used to examine if AF is re-inducible. If AF sustains or is re-inducible and physician decides to remap, mapping will be performed again for substrate-targeted ablation. If AF is not re-inducible, mCPVA will be completed
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 85 years of age
- •Persistent AF scheduled to undergo catheter ablation with approved standard indication by ESC/EHRA guidelines
- •First or second time ablation for persistent AF
- •Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule
排除标准
- •Had two or more previous AF ablation procedures
- •Secondary AF
- •Hyperthyroidism
- •Left ventricular ejection fraction <30%
- •NYHA functional class IV
- •Left atrial area > 35 cm2
- •Uncorrected severe valvular heart disease
- •Contraindication to anticoagulation
- •Presence of left atrial thrombus
- •Recent (<6 Months) myocardial Infarction or unstable angina or coronary artery by-pass
- •Thoracic surgery for congenital, valvular or aortic disease
- •History of cerebrovascular accidents
- •Pregnancy
- •Significant comorbidities such as cancer, severe renal insufficiency requiring hemodialysis, severe obstructive lung disease, cirrhosis, with a life expectancy less than 2 years
研究组 & 干预措施
mCPVA
Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF.
干预措施: mCPVA (Device)
Substrate+mCPVA
Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation.
干预措施: Substrate+mCPVA (Device)
结局指标
主要结局
Long-term Clinical Success Rate
时间窗: 12 months
Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.
次要结局
- Acute Ablation Procedure Outcome(During Ablation)