Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
NCT06458140

Cardioneuroablation and Ventricular Proarrhythmia

Led by Centre of Postgraduate Medical Education · Updated on 2025-05-14

50

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardioneuroablation and Ventricular Proarrhythmia

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe, recurrent symptoms due to reflex syncope with ECG documented asystole longer than 3 seconds
  • History of ineffective prior non-pharmacological treatment
  • Positive baseline atropine test (sinus rate acceleration over 30% and no atrio-ventricular block after 2 mg intravenous atropine)
  • Informed written consent to participate in the study
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, Poland, 04-073

Actively Recruiting

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Research Team

P

Piotr Kulakowski, MD PhD

CONTACT

A

Agnieszka Sikorska, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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