跳至主要内容
临床试验/NCT06202209
NCT06202209招募中不适用

The Impact of Autonomic Function on Recurrence Following Circumferential Pulmonary Vein Ablation for Atrial Fibrillation

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Autonomic nerve function assessment

研究概览

简要总结

This is a prospective and observational study. The investigator speculated that the use of DC in patients with paroxysmal AF can serve as a predictor for early and late AF recurrence following CPVI.

详细描述

Atrial fibrillation (AF), also known as atrial flutter, is one of the most common cardiac arrhythmias and poses a serious threat to patients' health and well-being. The mechanism of AF is complex, with the autonomic nervous system playing a crucial role in its initiation and maintenance. Currently, medication and ablation are the main treatment methods to reduce AF episodes, but the efficacy of drug therapy is limited, and recurrence after ablation still exists. Recent studies have found that changes in autonomic nervous system activity are one of the key factors contributing to AF recurrence after ablation. Therefore, by objectively assessing changes in autonomic nervous system activity, it is expected to improve the success rate of AF ablation and provide a potential cure for AF, with significant social and economic value.

Studies have found that pulmonary vein isolation (PVI) ablation is the mainstream method for AF ablation, and it affects the autonomic nervous system function. Patients who show significant changes in autonomic nervous system function after AF ablation have higher success rates. Additionally, early-onset atrial arrhythmias are closely related to long-term AF recurrence after ablation. However, the mechanisms underlying early recurrence still require further investigation.

Our research team has conducted in-depth studies on the regulation of autonomic nervous system function in the heart and non-invasive assessment techniques, achieving breakthrough progress. The left atrial ganglion plays a crucial role in the initiation and maintenance of AF, and ablating the ganglion can improve the success rate of AF ablation. Non-invasive assessment techniques such as heart rate deceleration can quantitatively evaluate changes in vagal nerve activity in the heart, which can be used to predict the efficacy of autonomic ganglion intervention therapy.

Based on the above research, our research team hypothesizes that precise and quantitative assessment of autonomic nervous system function using heart rate deceleration can predict AF recurrence after PVI ablation. To validate this hypothesis, we plan to conduct a prospective observational study, recruiting patients with paroxysmal AF, assessing changes in autonomic nervous system function, monitoring early-onset atrial arrhythmias and AF recurrence, and providing theoretical support for the screening and intervention of high-risk recurrence patients, laying a foundation for clinical application.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sign the informed consent form;
  • Clearly diagnosed as paroxysmal AF, willing to receive CPVI treatment;
  • A class I or class III antiarrhythmic drug with poor efficacy, or intolerance to drugs.

排除标准

  • Diagnosis of sinus rhythm at recruitment;
  • Age is <18 years old or> 75 years old;
  • Transthoracic echocardiography suggested a left atrial anterior and posterior diameter of> 55mm;
  • Previous history of catheter ablation or surgical ablation for AF;
  • Left atrial thrombus recorded by ultrasound or CT;
  • With severe pulmonary diseases;
  • Previous history of cardiac surgery;
  • Patients with hyperthyroidism, atrial septal defect, mitral valve stenosis or severe coronary heart disease who need further treatment;
  • During pregnancy or lactation.

结局指标

主要结局

Autonomic nerve function assessment

时间窗: 12 months after CPVI

The difference in DC values at 1 year compared to the preoperative baseline

Recurrence of AF at 1 year after surgery

时间窗: 12 months after CPVI

Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring

次要结局

  • Recurrence of AF at 3 months after surgery(3 months after CPVI)
  • Autonomic nerve function assessment(3 months after CPVI)
  • Recurrence of AF at 1 month after surgery(1 months after CPVI)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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