RecruitingNot ApplicableNCT06458140

Cardioneuroablation and Ventricular Proarrhythmia

Acute electRophysiOlogical Changes of Ventricular Myocardium Following cArdioneuroablatioN for Asystolic Reflex Syncope


Sponsor

Centre of Postgraduate Medical Education

Enrollment

50 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Cardioneuroablation (CNA) is a promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in sinus node acceleration and improved atrio-ventricular conduction, which in turn prevents vagally-mediated reflex asystole. However, lack of parasympathetic protection may potentially be proarrhythmic, especially on the ventricular level. Whether this is a real threat is not known. Therefore, the aim of our study is to assess acute effects of CNA-induced total vagal denervation, measured by extracardiac vagal stimulation, on ECG and electrophysiological parameters as well as vulnerability to ventricular arrhythmias. The study group will consist of 50 consecutive patients undergoing CNA in our institution. Cardioneuroablation will be performed in standard manner. The following parameters will be assessed at baseline and after CNA (directly after CNA, after atropine injected after CNA and after isoproterenol bolus injected at the very end of the procedure): QTc interval, QT dispersion, right ventricular action potential duration, right ventricular effective refractory period and susceptibility to complex ventricular arrhythmias using programmed ventricular stimulation.


Eligibility

Min Age: 14 Years

Inclusion Criteria4

  • severe, recurrent symptoms due to reflex syncope with ECG documented asystole \>3 seconds
  • history of ineffective prior non-pharmacological treatment
  • positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine)
  • informed written consent to participate in the study

Exclusion Criteria2

  • Lack of consent to participate in the study
  • Contraindications to perform right ventricular stimulation

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Interventions

PROCEDURECardioneuroablation

Radiofrequency ablation of ganglionated plexi of the heart


Locations(1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Poland

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NCT06458140


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