About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of consent to participate in the study
Contraindications to perform right ventricular stimulation
Trial design
Single group
Treatments tested in this trial
Cardioneuroablation
Procedure/SurgeryRadiofrequency ablation of ganglionated plexi of the heart
Treatment groups
Trial outcomes
Primary outcomes
Inducibility of ventricular arrhythmias
Programmed ventricular stimulation is used to assess vulnerability to ventricular arrhythmia at baseline and after cardioneuroablation
Secondary outcomes
Corrected QT interval
Standard ECG is used to assess corrected QT interval before and after cardioneuroablation
QT interval dispersion
Standard ECG is used to measure QT interval dispersion before and after cardioneuroablation
Right ventricular action potential duration
Intracardiac ECG recorded from the ablation electrode is used to measure right ventricular action potential duration before and after cardioneuroablation
Effective refractory period of the right ventricle
During programmed ventricular pacing using eight-beat drive and one extrastimulus delivered at progressively shortened coupling interval is used to assess effective refractory period of the right ventricle before and after cardioneuroablation
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