EARLY-MYO-AF (EARLY Integrated Therapies on MYOcardial Function Improvements in Patients With Atrial Fibrillation) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
The purpose of this registry is to depict the myocardial function improvement in AF patients by integrated therapy and to assess the prognostic discrepancies of various intervention modalities. Information will be collected prospectively in about 5000 AF patients. Subjects will be followed for up to 3 years.
详细描述
This is a prospective, single-centered, non-randomized, observational registry study of AF patients that undergo radio-frequency catheter ablation, left atrial appendage occlusion or surgical ablation. Information of other medication intervention and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 5000 AF patients with follow-ups of up to 3 years.
The aim of the project will be as following:
- To investigate pathophysiological changes of both atrial and ventricular myocardial function in AF patients.
- To identify clinical indices (including baseline, comorbidities, medication or operational interventions) that are associated with adverse clinical outcomes.
- To spot potential therapeutical targets in the continuum of AF: from risk-factors elimination to mortality and disability prevalence reduciton.
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
- •Eligible patients must be at least 18 years old at the time of enrollment.
- •Patients who are clinically indicated catheter ablation or other interventions (LAAC or surgical maze procedure) for persistent or long standing persistent AF.
排除标准
- •Contraindication for anticoagulation therapy
- •Another (non-AF) indication for long term anticoagulation
- •Patients who have been enrolled as a respondent on other clinical studies
- •Inability to attend scheduled, periodic office visits for follow-up
- •Pregnancy
- •Patient has a life expectancy of less than 6 months due to any condition.
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 3 years
A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality.
次要结局
- Major bleeding(3 years)