跳至主要内容
临床试验/NCT06472102
NCT06472102招募中不适用

Value of fRagmented Atrial electrOgrams, Computed Tomography and Intracardiac Echocardiography for Identification of optiMal Sites for Radio-frequency Delivery During cArdioneuroablation for Asystolic Reflex syNcope

Centre of Postgraduate Medical Education2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月20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
2
主要终点
Predictive value of fragmented atrial potentials

研究概览

简要总结

Cardioneuroablation (CNA) is a new method for the treatment of asystolic reflex syncope, however, optimal methods for identification of presumed sites of ganglionated plexi (GP), which are the target for CNA and are located in the epicardial fat, have not yet been established. This study will compare the accuracy of three methods used for identification of these areas: intracardiac recordings of fractionated atrial electrograms, intracardiac echocardiography and computed tomography. The study group will consist of 100 patients undergoing CNA in our institution. The procedure will be performed in a standard manner with the use of extracardiac vagal stimulation as the intraprocedural end-point. Correlation between the three methods used for localisation of optimal sites for CNA as well as their predictive value for achieving effective CNA will be computed.

详细描述

Cardioneuroablation (CNA) is a new method for the treatment of asystolic reflex syncope. Although the procedure is becoming more and more popular, many important issues remain unresolved. One such a problem is the optimal method for identification of presumed sites of ganglionated plexi (GP) which are located in the epicardial fat surrounding myocardium and are the target for CNA. Several methods have been used, including anatomical approach using computed tomography (CT), intracardiac echocardiography (ICE) and 3D electro-anatomical mapping (EAM) as well as electrophysiological methods which include high-frequency stimulation and recording of fragmented atrial potentials (FP).

Areas of FAP are sought to represent nerve fibers endings, extending from GPs to myocardium. The technique was first described by in 2004 and spectral analysis with fast Fourier transformation was used to identify these areas. Next, the time-domain quantification of FAP characteristics was performed. It was found that a high number of deflections (at least 4) identified the presumed areas of GPs. Later on, this method was further developed and it has been shown that FAP-guided CNA was associated with shorter procedure and fluoroscopy times. The currently advocated approach is to evaluate FAP for the number of deflections at filter settings of 200-500 Hz or 100-500 Hz. If ≥3 deflections are present, these sites are tagged as ablation targets.

However, the role of FAP for the identification of optimal sites for GPs ablation is still debatable. Reproducibility of the results of spectral analysis of GPs areas has not been well established. Also, sensitivity and specificity of both spectral and time-domain analysis of FAP have not been established. The sensitivity of 72% and specificity of 91% values were calculated for patients undergoing ablation for atrial fibrillation and not CNA, were based on reflex bradycardia/asystole during RF delivery, mainly at posterior left atrial (LA) wall and not by extra cardiac vagal stimulation (ECVS) after ablation at typical sites for septal GPs. In fact, specificity may be limited because FAP may represent areas of scarred atrial tissue, pulmonary vein (PV) potentials or fragmented electrograms at such areas in the right atrium (RA) as slow pathway region, coronary sinus (CS) os or RA-superior vena cava (SVC) junction. Moreover, the adipose tissue surrounding the heart can infiltrate the atrial myocardium, causing heterogeneous activation resulting in the presence of FAP. In addition, the sensitivity may also be limited since effective RF applications, which cause total vagal denervation confirmed by ECVS, can be sometimes performed at the areas with no FAP. To date, no study examined prospectively and blindly characteristics of FAP in effective and non-effective sites, confirmed by ECVS, in patients undergoing CNA due to reflex asystolic syncope.

Intracardiac echocardiography. This is another tool used for anatomical localisation of presumed GP areas. With ICE, areas of epicardial fat in the so-called pyramidal space, containing paraseptal inferior GP, as well as space between right superior PV (RSPV) and SVC, containing superior paraseptal GP, can be visualised. The correlation between ICE-identified areas of GPs and other tools like CT or FAP has not yet been established.

Computed tomography. Lastly, CT can be used during anatomical approach to identify target sites for CNA. Current techniques enable visualisation of pericardial fat. Also, density of the epicardial fat which may correspond to the density of GPs, can be quantified using CT.

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
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe, recurrent symptoms due to reflex syncope with ECG documented asystole >3 seconds, especially if associated with injury, or recurrent presyncope with persistent reflex bradycardia
  • history of ineffective prior non-pharmacological treatment and positive baseline atropine test (sinus rate acceleration > 30% and no AV block following 2 mg of intravenous atropine) -
  • informed written consent obtained

排除标准

  • contraindications to perform cardioneuroablation
  • contraindications to perform computed tomography with intravenous contrast injection
  • lack of informed written consent obtained

结局指标

主要结局

Predictive value of fragmented atrial potentials

时间窗: During procedure (2 hours)

Sensitivity, specificity, positive and negative predictive value of fragmented atrial potentials for the acute efficacy of cardioneuroablation

次要结局

  • Number of deflections of fragmented atrial potentials at inferior and superior areas of ganglionated plexi(During procedure (2 hours))
  • Duration of fragmented atrial potentials at inferior and superior areas of ganglionated plexi(During procedure (2 hours))
  • Amplitude of fragmented atrial potentials at inferior and superior areas of ganglionated plexi(During procedure (2 hours))
  • Localization of presumed areas of ganglionated plexi(During procedure (2 hours))
  • Accuracy of identification of sites where effective cardioneuroablation was performed(During procedure (2 hours))

研究者

发起方
Centre of Postgraduate Medical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Piotr Kulakowski

Professor

Centre of Postgraduate Medical Education

研究点 (2)

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