Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The relapse rate of atrial tachyarrhythmia
研究概览
简要总结
The study is designed as a randomized control trial. The purpose of this study is to observe the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.
详细描述
Basic studies suggested that sympathetic nerves over-activity played an important role in the pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting more than 30 seconds, the incidence of composite cardiovascular events after renal sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• ≥ 18 years old, and ≤ 75 years old of age
- •more than half a year history of atrial fibrillation, no matter paroxysmal or persistent, with clinical symptom or ECG proved
- •be ineffective to at least one kind of anti-arrhythmic drugs treatment
- •echocardiography has done to except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
- •estimated glomerular filtration rate (eGFR) of ≥ 45ml/min
- •is competent and willing to provide written, informed consent to participate in this clinical study
排除标准
- •• transesophageal echocardiography found thrombus in left atrial appendage
- •past history of atrial fibrillation surgical maze procedure
- •estimated glomerular filtration rate (eGFR) of < 45mL/min
- •has the history of renal restenosis or renal stents implantation
- •has experienced AMI（acute myocardial infarction） (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
- •patients with sick sinus syndrome
- •pregnant women
- •mental disorders
- •patients that have allergy to contrast agent
- •patients that do not go with follow-up
- •others such as researcher considers it is not appropriate to be included into the study
研究组 & 干预措施
CPVI+RSM group
Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation.
干预措施: CPVI plus renal sympathetic modification (Procedure)
CPVI group
Circumferential pulmonary vein isolation is done alone for atrial fibrillation.
干预措施: CPVI (Procedure)
结局指标
主要结局
The relapse rate of atrial tachyarrhythmia
时间窗: Four years
Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed
次要结局
未报告次要终点
研究者
Yuehui Yin
Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center
The Second Affiliated Hospital of Chongqing Medical University