Comparative Study of Right Atrial Versus Bi-atrial Cardioneuroablation of Asystolic Reflex Syncope Verified by Implantable Loop Recorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mounthly frequency of asystolic episodes >3 sec
研究概览
简要总结
The study aims to determine which method of vagal ganglia ablation is most effective in preventing recurrences of reflex asystole syncope. Currently, some centers perform ablation only in the right atrium, others in both atria (biatrial). There are no comparative studies between the two procedures
详细描述
Cardioneuroablation (CNA) therapy for reflex asystole syncope is becoming increasingly popular. The best method of CNA is debated, with no studies comparing the syncopal recurrence rates of right atrium ablation versus bi-atrial ablation. Evaluating the clinical efficacy of CNA is challenging due to symptom variability, intermittent presentation, complex pathophysiology, and different treatment options. The difficulty of obtaining precise follow-up data in patients with intermittent symptoms is well known. With ILR, more objective tracking can be achieved.
The aim of the study is to verify the efficacy of CNA on the reduction of the asystole reflex documented by continuous monitoring by ILR in patients undergoing right atrial ablation compared to bi-atrial ablation
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 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years
- •Clinical diagnosis of reflex syncope as per class I criteria of the ESC guidelines
- •History of recurrent severe syncopes (≥2 in the last year or ≥3 in the last 2 years), significantly affecting the quality of life, nonresponding to lifestyle measures.
- •Documentation by means of prolonged ECG monitoring of an asystolic pause >6 sec or of an asystolic syncope >3 sec and/or an asystolic syncope induced during tilt testing (Vasis 2B form).
排除标准
- •Intrinsic sinus dysfunction or atrioventricular node disease.
- •Constitutional hypotension and orthostatic intolerance syndromes
- •Overt structural heart disease
- •Alternative diagnoses of syncope
- •Pregnancy or breastfeeding
结局指标
主要结局
Mounthly frequency of asystolic episodes >3 sec
时间窗: through study completion, an average of 1 year
Frequency of asystolic episodes \>3 sec per month detected through ILR monitoring before and after ablation.
Freedom from ablation-related complications
时间窗: through study completion, an average of 1 year
Freedom from ablation-related complications and from pacemaker implantation during the follow-up period;
次要结局
- heart rate (HR) and heart rate variability (HRV)(through study completion, an average of 1 year)
- Burden of syncopal episodes(through study completion, an average of 1 year)
- Time to first asystolic and syncope recurrence(through study completion, an average of 1 year)