Efficacy of Transcatheter Ablation of Ganglionic Plexuses (Cardioneuroablation) in Right Atrium in Patients With Asystolic Neuromediated Syncope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Intrapatient incidence of asystolic episodes before and after cardioneuroablation
研究概览
简要总结
Multicenter Italian interventional "proof of efficacy" clinical trial that aims to evaluate the incidence of asystolic pauses and heart rate in patients with CNS who performed severe CNA identified through asystolic pauses identification by implantable loop recorder. The study is independent, "investigator-initiated," sponsored by a nonprofit scientific association called the Italian Multidisciplinary Group for the Study of Syncope (GIMSI).
详细描述
The so called "Cardioneuroablation (CNA)" focused on the endocardial ablation of atrial ganglionated plexi has proven to be efficacy in patients affected by neuro-mediated cardioinhibitory syncope (NCS). No center currently has sufficient case series to establish long-term efficacy and safety results, for which a multicenter interventional study is therefore needed.
The aim of the study will be to evaluate the efficacy and safety of CNA focused in NCS patients. The ablation procedure, consists of radiofrequency delivering at right atrial anatomic sites where the underlying presence of GP clusters is regarded as highly probable: 1) the inferior-posterior area (first ablation site): inferior right GP placed between inferior vena cava, coronary sinus ostium and near the atrio-ventricular groove, 2) the superior-posterior area (second ablation site): superior right atrial GP, adjacent to the junction of the superior vena cava and the posterior surface of RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years
- •Patients with a clinical diagnosis of neuromediated syncope according to class I criteria of the ESC guidelines, Table 1
- •Clinical history of recurrent syncope (≥2 in the last year or ≥3 in the last 2 years), severe, not tolerated by the patient
- •Documentation of ≥2 asystolic pauses >3 sec daytime on ECG monitoring by implantable loop recorder (ILR), with or without syncope
- •Refusal by patient to perform pacemaker implantation
- •Tilt test is recommended but not mandatory. Patients with negative tilt test are also enrollable. It can be either positive or negative.
排除标准
- •Absence of sinus dysfunction and atrioventricular node disease.
- •Absence of structural heart disease
- •Possible alternative diagnoses of syncope
研究组 & 干预措施
patients affected by Cardioinhibitory Neurocardiogenic Syncope
干预措施: Transcatheter ablation of cardiac ganglionated plexi (Procedure)
结局指标
主要结局
Intrapatient incidence of asystolic episodes before and after cardioneuroablation
时间窗: through study completion, an average of 1 year
frequency (number and percentage) of asystolic episodes before and after ablation
次要结局
- Comparison of mean heart rate, before and after cardioneuroablation, incidence of (pre)syncopal episodes before and after CNA and, finally, beat-to beat HR variability during ILR monitoring(through study completion, an average of 1 year)
研究者
Leonardo Calò, MD
Professor
Policlinico Casilino ASL RMB