Cardioneuroablation and Ventricular Proarrhythmia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorCentre of Postgraduate Medical Education

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Cardioneuroablation

    Procedure/Surgery

    Radiofrequency ablation of ganglionated plexi of the heart

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Inducibility of ventricular arrhythmias

Programmed ventricular stimulation is used to assess vulnerability to ventricular arrhythmia at baseline and after cardioneuroablation

Time frame
2 hours

Secondary outcomes

1

Corrected QT interval

Standard ECG is used to assess corrected QT interval before and after cardioneuroablation

Time frame
2 hours
2

QT interval dispersion

Standard ECG is used to measure QT interval dispersion before and after cardioneuroablation

Time frame
2 hours
3

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

Time frame
2 hours
4

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

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.