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Recruiting Not applicable

Cardioneuroablation and Ventricular Proarrhythmia

NCT06458140 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2024-05-20
Last updated
2025-05-14

Condition(s) studied

Syncope, Vasovagal

Investigational drug(s) / intervention(s)

Cardioneuroablation

Cardioneuroablation: Radiofrequency ablation of ganglionated plexi of the heart

Study 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

Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Lack of consent to participate in the study * Contraindications to perform right ventricular stimulation

Primary outcome measure(s)

  • Inducibility of ventricular arrhythmias — 2 hours
    Programmed ventricular stimulation is used to assess vulnerability to ventricular arrhythmia at baseline and after cardioneuroablation

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital Warsaw Poland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06458140 on ClinicalTrials.gov ↗ ← All trials in Poland