First-time Ablation of Atrial Fibrillation Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Late AF recurrence
研究概览
简要总结
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.
The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers.
详细描述
AF is a multifactorial disease influenced by many possible mechanisms. This study will examine several different predictors of successful AF ablation: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. Analysis of these factors will help determine the optimal combination of predictors of successful ablation. This combination of prognostic factors can then be used to tailor therapeutic decisions specifically to individual patients and to improve patient selection for invasive treatment. Better patient selection and choice of ablation type can help increase success rates and avoid unnecessary procedures and their associated risks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •paroxysmal or persistent AF
- •first-time ablation of AF
排除标准
- •patients unable to give informed consent
- •serious health condition existing before ablation
结局指标
主要结局
Late AF recurrence
时间窗: 3-12 months after ablation
Late AF recurrence
次要结局
- Progression or regression of AF(3-12 months after ablation)
- Ablation procedure parameters(At ablation)
- Late recurrence of AF or atrial tachycardia or atrial flutter(3-12 months after ablation)
- AF-related quality of life and symptoms(Before, 3 and 12 months after ablation)
- Cardiac remodelling(Before, 3 and 12 months after ablation)
- Early recurrence of AF(<3 months after ablation)
- Early recurrence of AF or atrial tachycardia or atrial flutter(<3 months after ablation)
- Time to AF recurrence and the impact of early recurrence on late AF recurrence(<3 and 3-12 months after ablation)
- Modification of treatment, including antiarrhythmic treatment(3-12 months after ablation)
- Periprocedural complications(Around ablation)
- Heart rate variability and rate(<3 months after ablation)
- The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring(3 months after ablation)
- Blood biomarker levels(Before, 3 and 12 months after ablation)