Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 主要终点
- the frequency of recurrence
研究概览
简要总结
To generate real world evidence to compare clinical outcomes and patient health-related quality of life, resulting from catheter ablation therapy with clinical outcome and patient health-related quality of life resulting from drug therapy in China. An economic model will be constructed, and using the clinical events evidence collected in this study, and China long-term disease progression and local disease cost data to perform a cost-effectiveness evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF) patients.
详细描述
The evidence generated by this study is expected to help inform medical decision makers with the clinical and economic data of therapy for AF patients, and also provide policy decision makers with information that can be considered /used to allocate funds for AF ablation and permit patients to have access to appropriate treatment options for AF management.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients with paroxysmal or persistent AF eligible for catheter ablation
- •Age 18 to 80 years
- •Able and willing to comply with all pre,post and follow-up testing and requirements.
- •Be able to sign IRB/EC approved informed consent form.
排除标准
- •Terminal illness with a life expectancy less than 1 year.
- •New York Heart Association (NYHA) Class III or IV
- •Previous recipient of catheter ablation therapy for AF
- •Bradycardia and previous recipient of pacemaker therapy
- •Previous recipient RFCA or ICD therapy
- •Uncontrolled hypertension
- •Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
- •Patients with serious hepatic and renal diseases
- •Pregnant or prepare to be pregnant in one year
- •For drug therapy arm, if the subject cannot be contacted via phone or the subject shows his/her disagreement to this study at 30 day window, the subject will be withdrawn from this study.
结局指标
主要结局
the frequency of recurrence
时间窗: 9 months followup after baseline
the frequency of recurrence of Atrial Fibrillation/Flutter/Tachycardia
次要结局
- Rate(9 months from baseline)
- total cost(9 months follow up)
- Duration(9 months from baseline)