Focal Electrical Source and Trigger Mapping During Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to first symptomatic atrial fibrillation recurrence postablation
研究概览
简要总结
Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide with a prevalence of 8% in the elderly. AF is responsible for frequent hospitalizations, stroke, heart failure and mortality. AF catheter ablation is an important treatment strategy for patients suffering from AF, but the success rate remains low after conventional pulmonary vein isolation (PVI). The mechanism perpetuating AF is poorly understood. Focal electrical sources and triggers (FAST) may sustain AF in some patients, which makes them a potential therapeutic target for ablation. However, finding FAST is very challenging due to complex nature of AF electrical signals. In this study, the investigators will attempt to localize focal electrical sources and triggers (FAST mapping) in patients undergoing AF ablation using custom software that evaluates periodicity and waveform morphology. Patients will be randomized to one of two AF ablation strategies, namely FAST mapping/ablation + PVI vs. PVI alone. The investigators will determine which strategy leads to better clinical outcome postablation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be over the age 18 and have a clinical indication for their first catheter ablation of AF because of symptomatic AF.
- •This will include patients with either high burden paroxysmal (>4 self-terminating episodes of AF within the last 6 months with two episodes lasting at least 6 hours within the last year) or persistent AF (lasting ≥7 days, but which can still be converted to sinus rhythm).
排除标准
- •The major exclusion criteria will include:
- •long-standing persistent AF (ie. AF which cannot be converted to sinus rhythm, or where multiple attempts at restoring sinus rhythm have failed)
- •rheumatic valvular disease
- •hypertrophic cardiomyopathy
- •uncorrected cardiac shunts (eg. secundum ASD)
- •severe mitral regurgitation or mechanical mitral valve
- •left atrial size >55 mm (echo derived parasternal long axis view).
结局指标
主要结局
Time to first symptomatic atrial fibrillation recurrence postablation
时间窗: 3 months postablation
次要结局
未报告次要终点
研究者
Vijay Chauhan
Cardiologist
University Health Network, Toronto